FDA 510(k) Applications for Medical Device:
Lacrimal Stents And Intubation Sets
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K160710 | ANODYNE |
804 CORPORATE CENTRE DRIVE | O' FALLON | MO | 63368 |
| K113508 | ARMADILLO BIOMEDICAL, LLC |
3722 AVE SAUSALITO | IRVINE | CA | 92606 |
| K142914 | ARMADILLO BIOMEDICAL, LLC |
5363 Balbao Blvd., Suite 246 | Encino | CA | 91316 |
| K973872 | ATRION MEDICAL PRODUCTS, INC. |
1426 CURT FRANCIS RD. | ARAB | AL | 35016 |
| K973633 | ATRION MEDICAL PRODUCTS, INC. |
1426 CURT FRANCIS RD. | ARAB | AL | 35016 |
| K113316 | DCS SURGICAL INC |
1110 LINDEN AVE. | BOULDER | CO | 80304 |
| K030353 | EAGLE VISION, INC. |
8500 WOLF LAKE DR. | MEMPHIS | TN | 38133 |
| K161373 | FCI (FRANCE CHIRURGIE INSTRUMENTATION) |
20-22 RUE LOUIS ARMAND | PARIS | 75015 | |
| K201606 | FCI (France Chirurgie Instrumentation) SAS |
20-22 rue Louis Armand | Paris | 75015 | |
| K201892 | FCI (France Chirurgie Instrumentation) SAS |
20-22 rue Louis Armand | Paris | 75015 | |
| K023758 | FCI OPHTHALMICS, INC. |
344 ANNABELLE POINT RD. | CENTERVILLE | MA | 02632-2402 |
| K991238 | FCI OPHTHALMICS, INC. |
P.O. BOX 465 | MARSHFIELD HILLS | MA | 02051 |
| K061404 | FCI OPHTHALMICS, INC. |
344 ANNABELLE POINT RD. | CENTERVILLE | MA | 02632-2402 |
| K041869 | FCI OPHTHALMICS, INC. |
P.O. BOX 465 | MARSHFIELD HILLS | MA | 02051 |
| K121142 | FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
3308 JEFFERSON AVENUE | CINCINNATI | OH | 45220 |
| K113536 | FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
3308 JEFFERSON AVENUE | CINCINNATI | OH | 45220 |
| K130375 | FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
3308 JEFFERSON AVENUE | CINCINNATI | OH | 45220 |
| K123831 | FRANCE CHIRURGAE INSTRUMENTATION |
3308 JEFFERSON AVE | CINCINNATI | OH | 45220 |
| K955671 | G.W.B. INTL., LTD. |
P.O. BOX 465 | MARSHFIELD | MA | 02051-0465 |
| K120886 | HIROYASU HIGUCHI |
4-1 17 HONGO, BUNKYO-KU | TOKYO | 113-0033 | |
| K990672 | HURRICANE MEDICAL |
2331K 63RD AVE. EAST | BRADENTON | FL | 34203 |
| K170247 | KANEKA PHARMA AMERICA LLC |
546 FIFTH AVE., 21ST FLOOR | NEW YORK | NY | 10036 |
| K140290 | LJT SURGICAL LTD |
5600 WISCONSIN AVE. #509 | CHEVY CHASE | MD | 20815 |
| K012108 | POREX SURGICAL, INC. |
15 DART RD. | NEWNAN | GA | 30265 |
| K113867 | QUEST MEDICAL, INC. |
ONE ALLENTOWN PKWY. | ALLEN | TX | 75002 |
| K113118 | QUEST MEDICAL, INC. |
ONE ALLENTOWN PKWY. | ALLEN | TX | 75002 |
| K962151 | RYDER INTL. CORP. |
1426 CURT FRANCIS RD. | ARAB | AL | 35016 |
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