FDA 510(k) Applications for Medical Device:
Devices, Breath Trapping, Alcohol
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K093143 | ACON LABORATORIES, INC. |
10125 MESA RIM RD. | SAN DIEGO | CA | 92121 |
| K062971 | Akers Biosciences, Inc. |
201 GROVE RD. | THOROFARE | NJ | 08086 |
| K060761 | Akers Biosciences, Inc. |
201 GROVE RD. | THOROFARE | NJ | 08086 |
| K102338 | Akers Biosciences, Inc. |
201 GROVE RD. | THOROFARE | NJ | 08086 |
| K102225 | ALCOPRO, INC. |
1560 E. EDINGER AVENUE, | SANTA ANA | CA | 92705 |
| K082080 | ALCOTEST QUEBEC |
1468 HARWELL AVE | CROFTON | MD | 21114 |
| K081855 | CANADA, INC. |
1100 HAMMOND DR. | ATLANTA | GA | 30328 |
| K052448 | CONNECTABLES, LLC |
2340 ERNIE KRUEGER CIRCLE | WAUKEGAN | IL | 60087 |
| K100879 | CONTRALCO |
144 RESEARCH DRIVE | HAMPTON | VA | 23666 |
| K063443 | DRAGER SAFETY |
333 ALPINE STREET | EMMAUS | PA | 18049 |
| K041334 | KHN SOLUTIONS, LLC |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K071067 | KHN SOLUTIONS, LLC |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K090067 | KHN SOLUTIONS, LLC |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K083801 | KHN SOLUTIONS, LLC |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K090766 | LIFELOC TECHNOLOGIES, INC. |
12441 W. 49TH AVE. | WHEAT RIDGE | CO | 80033 |
| K052804 | OMEGAPOINT SYSTEMS, LLC |
310 TERRACE AVENUE, SUITE 201 | CINCINNATI | OH | 45220 |
| K123470 | PAS SYSTEMS INTERNATIONAL, INC. |
1616 PRINCESS ANNE STREET | FREDERICKSBURG | VA | 22401 |
| K080848 | Q3 INNOVATIONS, LLC |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K043188 | Q3 INNOVATIONS, LLC |
P.O. BOX 7007 | DEERFIELD | IL | 60015 |
| K072953 | REDLINE PRODUCTS (PTY) LTD. |
10 CROMPTON ROAD | STRAND INDUSTRIA, WESTERN CAPE | 7140 | |
| K062545 | RESOURCE MANAGEMENT INTERNATIONAL, LLC |
2330 ERNIE KRUEGER CIRCLE | WAUKEGAN | IL | 60087 |
| K110614 | SEJU ENGINEERING CO., LTD. |
CERTIFICATION DIVISION | YUSEONG-GU, DAEJEON | 305-500 | |
| K053332 | SENTECH KOREA CORP. |
21 GRAND AVE. SUITE 103 | PALISADES PARK | NJ | 07650 |
| K061922 | SENTECH KOREA CORP. |
1460-1 SEOYANG B/D | SEOUL | 13786 | |
| K060343 | SENTECH KOREA CORP. |
21 GRAND AVE. SUITE 103 | PALISADES PARK | NJ | 07650 |
| K091714 | SKYFINE INC. LIMITED |
NO.45, MINSHENG RD., DANSHUI | TAIPEI COUNTY | 251 | |
| K160613 | SOBERLINK HEALTHCARE LLC |
16787 BEACH BLVD #211 | HUNTINGTON BEACH | CA | 92647 |
| K082086 | THE ASHLEY COLLECTION, INC. |
600 WEST 57TH ST. | NEW YORK | NY | 10019 |
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