FDA 510(k) Applications for Medical Device:
Spatula, Cervical, Cytological
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983428 | ANDWIN SCIENTIFIC |
6636 VARIEL AVE. | CANOGA PARK | CA | 91303 |
| K983599 | ANDWIN SCIENTIFIC |
6636 VARIEL AVE. | CANOGA PARK | CA | 91303 |
| K081522 | BIO NUCLEAR DIAGNOSTICS, INC. |
1791 ALBION RD. | TORONTO, ONTARIO | M9W 5S7 | |
| K980356 | CANADIAN MEDICAL BRUSH, INC. |
2299 DREW RD. | MISSISSAUGA | L55 1A3 | |
| K960469 | COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. | SPENCER | IN | 47460 |
| K072381 | CYTOCORE, INC. |
414 NORTH ORLEAN | CHICAGO | IL | 60610 |
| K062433 | DIAMICS, INC. |
SIX HAMILTON LANDING SUITE 200 | NOVATO | CA | 94949 |
| K971586 | DIGENE CORP. |
9000 VIRGINIA MANOR RD., | BELTSVILLE | MD | 20705 |
| K041018 | DOCTOR'S RESEARCH GROUP, INC. |
50 ALTAIR AVE. | PLYMOUTH | CT | 06782 |
| K182049 | ExCell Company LLC |
1540 West Main Street | Carmel | IN | 46032 |
| K961934 | HARDWOOD PRODUCTS CO., LP |
P.O. BOX 149, 31 SCHOOL ST. | GUILFORD | ME | 04443 |
| K983202 | HARWILL MEDICAL (PTY) LTD. |
P O BOX 4341 | CROFTON | MD | 21114 |
| K153128 | KOLPLAST CI SA |
ESTRADA MUNICIPAL IVA 136. NO 418. BARRIO DA MINA | ITUPEVA- SP | 13295-000 | |
| K042527 | MEDICAL ACTION INDUSTRIES, INC. |
25 HEYWOOD RD. | ARDEN | NC | 28704 |
| K013258 | MOLECULAR DIAGNOSTICS |
414 N. ORLEANS | CHICAGO | IL | 60610 |
| K141057 | NINGBO HLS MEDICAL PRODUCTS CO., LTD |
3500 SOUTH DUPONT HIGHWAY | DOVER | DE | 19901 |
| K963685 | NORTH EOS INDUSTRIES, INC. |
54, LANE 1, BEEN ST. | TAICHUNG HSIEN 423 | ||
| K991593 | ORIFICE MEDICAL AB |
BRONSGATAN 12 | YSTAD | S-271 39 | |
| K991595 | ORIFICE MEDICAL AB |
BRONSGATAN 12 | YSTAD | S-271 39 | |
| K083012 | OTTO BOCK PUR LIFE SCIENCE GMBH |
MAX-NAEDER-STR 15 | DUDERSTADT, LOWER SAXONY | 37115 | |
| K111681 | PURITAN MEDICAL PRODUCTS COMPANY LLC |
31 SCHOOL ST. | GUILFORD | ME | 04443 |
| K043369 | ROVERS MEDICAL DEVICES B.V. |
LEKSTRAAT 10 | OSS | 5347 KV | |
| K001119 | ROVERS MEDICAL DEVICES B.V. |
960 CHAPEA RD. | PASADENA | CA | 91107 |
| K002520 | ROVERS MEDICAL DEVICES B.V. |
960 CHAPEA RD. | PASADENA | CA | 91107 |
| K971849 | TEAM TECHNOLOGIES, INC. |
5949 COMMERCE BLVD. | MORRISTOWN | TN | 37814 |
| K963801 | YOUNG OU BRUSH CO. |
966-114 KANG KEUN-DONG | KYONG BUK |
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