The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Advance Laparotomy Sponge, Lap Sponge.
| Device ID | K903358 |
| 510k Number | K903358 |
| Device Name: | ADVANCE LAPAROTOMY SPONGE, LAP SPONGE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | Ronald D Arkin |
| Correspondent | Ronald D Arkin ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-26 |
| Decision Date | 1990-11-29 |