The following data is part of a premarket notification filed by Medical Insights, Inc. with the FDA for Non-woven Sponge.
| Device ID | K940901 |
| 510k Number | K940901 |
| Device Name: | NON-WOVEN SPONGE |
| Classification | Gauze/sponge, Internal |
| Applicant | MEDICAL INSIGHTS, INC. 193 WHITEHALL AVE. Mystic, CT 06355 |
| Contact | Robert J Caricato |
| Correspondent | Robert J Caricato MEDICAL INSIGHTS, INC. 193 WHITEHALL AVE. Mystic, CT 06355 |
| 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 | 1994-02-24 |
| Decision Date | 1994-03-31 |