The following data is part of a premarket notification filed by Medical Products Search, Inc. with the FDA for Hema(pro)tec(tion).
| Device ID | K885324 |
| 510k Number | K885324 |
| Device Name: | HEMA(PRO)TEC(TION) |
| Classification | Tube, Collection, Capillary Blood |
| Applicant | MEDICAL PRODUCTS SEARCH, INC. 2596 REYNOLDA RD. SUITE D Winston-salem, NC 27106 |
| Contact | Michael P Bradley |
| Correspondent | Michael P Bradley MEDICAL PRODUCTS SEARCH, INC. 2596 REYNOLDA RD. SUITE D Winston-salem, NC 27106 |
| Product Code | GIO |
| CFR Regulation Number | 864.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-28 |
| Decision Date | 1989-02-17 |