The following data is part of a premarket notification filed by Asia Dynamics, Inc. with the FDA for Adi Sterile Gauze Sponges.
| Device ID | K953501 |
| 510k Number | K953501 |
| Device Name: | ADI STERILE GAUZE SPONGES |
| Classification | Gauze/sponge, Internal |
| Applicant | ASIA DYNAMICS, INC. 5745 WEST HOWARD ST. Niles, IL 60714 |
| Contact | Christi Gerard |
| Correspondent | Christi Gerard ASIA DYNAMICS, INC. 5745 WEST HOWARD ST. Niles, IL 60714 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-26 |
| Decision Date | 1995-08-28 |