The following data is part of a premarket notification filed by Frastec Wound Care Products, Inc. with the FDA for Frastec Conformant Dressing, Various Sizes.
| Device ID | K885325 |
| 510k Number | K885325 |
| Device Name: | FRASTEC CONFORMANT DRESSING, VARIOUS SIZES |
| Classification | Dressing, Wound, Drug |
| Applicant | FRASTEC WOUND CARE PRODUCTS, INC. 3830 BOSTON RD. Bronx, NY 10475 |
| Contact | A Malia |
| Correspondent | A Malia FRASTEC WOUND CARE PRODUCTS, INC. 3830 BOSTON RD. Bronx, NY 10475 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-28 |
| Decision Date | 1989-04-17 |