FDA 510(k) Applications for Medical Device:
Saliva, Artificial
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K091718 | BARTOR PHARMACAL CO., INC. |
25 RAVENNA DRIVE | POMONA | NY | 10970 |
| K142657 | BIO COSMETICS, S.L. |
CALLE ARAQUIL, 11 | MADRID | 28023 | |
| K072306 | BIO-X HEALTHCARE S.A. |
1601 K STREET NW | WASHINGTON | DC | 20036 |
| K120552 | BIOCOSMETICS LABORATORIES |
57 LAZY BROOK RD | MONROE | CT | 06468 |
| K163029 | BIOPHARM CONSULT, L.L.C. |
5609 HARD ROCK PLACE | HENRICO | VA | 23230 |
| K111250 | DR. FRESH, INC. |
MEDICAL DEVICES | HAMPTON | VA | 23666 |
| K171542 | Dr. Harold Katz, LLC (dba TheraBreath |
5802 Willoughby Avenue | Los Angeles | CA | 90038 |
| K150074 | ELEVATE ORAL CARE |
346 PIKE ROAD | WEST PALM BEACH | FL | 33411 |
| K162167 | EUSA Pharma (UK) Limited |
Breakspear Park, Breakspear Way | Hemel Hempstead | HP2-4TZ | |
| K152406 | FORWARD SCIENCE LLC |
3944 Bluebonnet Dr. | Stafford | TX | 77477 |
| K101346 | GC AMERICA, INC. |
3737 W. 127TH ST. | ALSIP | IL | 60803 |
| K981693 | GEBAUER CO. |
9410 ST. CATHERINE AVE. | CLEVELAND | OH | 44104 |
| K101477 | GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) |
1500 LITTLETON ROAD | PARSIPPANY | NJ | 07054 |
| K103745 | GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) |
1500 LITTLETON ROAD | PARSIPPANY | NJ | 07054 |
| K123731 | GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) |
1500 LITTLETON ROAD | PARSIPPANY | NJ | 07054 |
| K041563 | GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. |
1500 LITTLETON RD. | PARSIPPANY | NJ | 07054 |
| K231205 | GuruNanda LLC |
6645 Caballero Blvd. | Buena Park | CA | 90620 |
| K030802 | INPHARMA A.S. |
96 WEST MAIN ST. | NORTHBOROUGH | MA | 01532 |
| K991938 | INPHARMA A.S. |
P.O. BOX 809, 27 SOUTH ST. | NORTHBOROUGH | MA | 01532 |
| K093642 | INVADO PHARMACEUTICALS |
25 RAVENNA DRIVE | POMONA | NY | 10970 |
| K142549 | J.C.E.C. Company, Inc. (doing business as Fountain Health Ca |
12 Frieda Lane | Kendall Park | NJ | 08824 |
| K173808 | Jeffrey Ward Cash, DDS |
10149 Bon Air Crest Drive | North Chesterfield | VA | 23235-4868 |
| K051812 | LABORATOIRES CARILENE S.A.S. |
1800 MASSACHUSETTS AVE., NW | WASHINGTON | DC | 20036 |
| K061331 | LACLEDE, INC. |
2103 EAST UNIVERSITY DR. | RANCHO DOMINQUEZ | CA | 90220 |
| K180680 | Laclede, Inc. |
2103 E. University Dr. | Rancho Dominguez | CA | 90220 |
| K110116 | LORIN TECHNOLOGIES CORPORATION |
436 WOODLAND DR | SWANSBORO | NC | 28584 |
| K152201 | MedActive Oral Pharmaceuticals, LLC. |
1900 Gunn Highway | Odessa | FL | 33556 |
| K071617 | ORAL BIOTECH |
812 WATER ST. NE | ALBANY | OR | 97321 |
| K181839 | OraLabs, Inc. |
18685 East Plaza Drive | Parker | CO | 80134 |
| K202689 | Oxy2plus, LLC |
4120 Rosemead Blvd | Rosemead | CA | 91770 |
| K062653 | PARNELL PHARMACEUTICALS, INC. |
1525 FRANCISCO BLVD., STE. 15 | SAN RAFAEL | CA | 94901 |
| K122663 | QUANTUM, INC. |
7195 LONGVIEW DRIVE | CLEVELAND | OH | 44139 |
| K024148 | SINCLAIR PHARMACEUTICALS, LTD. |
BOROUGH RD. | GODALMING, SURREY | GU7 2AB | |
| K190144 | SunBio, Inc. |
95 Sanbon-ro | Gunpo-si | 15849 | |
| K181134 | Sunstar Americas Inc |
301 E. Central Road | Schaumburg | IL | 60195 |
| K173237 | Syendgen, Inc. |
1420 N. Claremont Blvd. Suite 105D | Claremont | CA | 91711 |
| K091419 | THE PROCTER & GAMBLE CO. |
8700 MASON-MONTGOMERY ROAD | MASON | OH | 45040 |
| K201277 | The Procter & Gamble Company |
1 Procter & Gamble Plaza | Cincinnati | OH | 45202 |
| K203567 | The Procter & Gamble Company |
1 Procter & Gamble Plaza | Cincinnati | OH | 45202 |
| K181194 | Triumph Pharmaceuticals, Inc. |
12312 Olive Blvd., Ste. 250 | St. Louis | MO | 63141 |
| K163476 | You First Services, Incorporated |
1576 Sweet Home Road | Amherst | NY | 14228 |
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