The following data is part of a premarket notification filed by Carwild Corp. with the FDA for Lap Sponges, Modified.
| Device ID | K913303 |
| 510k Number | K913303 |
| Device Name: | LAP SPONGES, MODIFIED |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | CARWILD CORP. SEAPORT CAMPGROUND RD. P.O. BOX 512 Old Mystic, CT 06372 |
| Contact | Joel S Wildstein |
| Correspondent | Joel S Wildstein CARWILD CORP. SEAPORT CAMPGROUND RD. P.O. BOX 512 Old Mystic, CT 06372 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-25 |
| Decision Date | 1992-08-06 |