The following data is part of a premarket notification filed by Kerma Medical Products, Inc. with the FDA for Multiple Sterile Gauze Bandage Rolls, Vari Sizes.
| Device ID | K915821 |
| 510k Number | K915821 |
| Device Name: | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | KERMA MEDICAL PRODUCTS, INC. 1801-P SARA DR. Chesapeake, VA 23320 |
| Contact | Bessie N Todd |
| Correspondent | Bessie N Todd KERMA MEDICAL PRODUCTS, INC. 1801-P SARA DR. Chesapeake, VA 23320 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-30 |
| Decision Date | 1992-05-29 |