The following data is part of a premarket notification filed by Carwild Corp. with the FDA for Disposable Specialty Sponges (dissectors)/modified.
| Device ID | K913302 |
| 510k Number | K913302 |
| Device Name: | DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/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 | 1992-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704599428 | K913302 | 000 |
| 24026704417715 | K913302 | 000 |
| 24026704417708 | K913302 | 000 |
| 24026704417692 | K913302 | 000 |
| 24026704417678 | K913302 | 000 |
| 24026704417661 | K913302 | 000 |
| 24026704417654 | K913302 | 000 |
| 24026704417647 | K913302 | 000 |
| 24026704417630 | K913302 | 000 |
| 24026704417616 | K913302 | 000 |
| 24026704417609 | K913302 | 000 |
| 24026704599411 | K913302 | 000 |
| 24026704417722 | K913302 | 000 |
| 24026704417739 | K913302 | 000 |
| 24026704417845 | K913302 | 000 |
| 24026704417838 | K913302 | 000 |
| 24026704417821 | K913302 | 000 |
| 24026704417814 | K913302 | 000 |
| 24026704417807 | K913302 | 000 |
| 24026704417791 | K913302 | 000 |
| 24026704417784 | K913302 | 000 |
| 24026704417777 | K913302 | 000 |
| 24026704417760 | K913302 | 000 |
| 24026704417753 | K913302 | 000 |
| 24026704417746 | K913302 | 000 |
| 24026704417852 | K913302 | 000 |