The following data is part of a premarket notification filed by Eagle Medical, Inc. with the FDA for Sterile Gauze Pads.
| Device ID | K915591 |
| 510k Number | K915591 |
| Device Name: | STERILE GAUZE PADS |
| Classification | Gauze / Sponge,nonresorbable For External Use |
| Applicant | EAGLE MEDICAL, INC. 160 CORPORATE WOODS COURT P.O. BOX 640 Bridgeton, MO 63044 |
| Contact | Arnold Lerman |
| Correspondent | Arnold Lerman EAGLE MEDICAL, INC. 160 CORPORATE WOODS COURT P.O. BOX 640 Bridgeton, MO 63044 |
| Product Code | NAB |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-13 |
| Decision Date | 1993-01-27 |