The following data is part of a premarket notification filed by A.r. Medicom, Inc. with the FDA for Medicom Non-woven Sponges.
| Device ID | K935257 |
| 510k Number | K935257 |
| Device Name: | MEDICOM NON-WOVEN SPONGES |
| Classification | Gauze/sponge, Internal |
| Applicant | A.R. MEDICOM, INC. 910 RUE BEGIN ST. LAURENT, Quebec, H4m 2n5 Canada, CA H4m 2n5 |
| Contact | Ronald Reuben |
| Correspondent | Ronald Reuben A.R. MEDICOM, INC. 910 RUE BEGIN ST. LAURENT, Quebec, H4m 2n5 Canada, CA H4m 2n5 |
| 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 | 1993-11-01 |
| Decision Date | 1994-04-14 |