The following data is part of a premarket notification filed by Advanced Surgical, Inc. with the FDA for Tissue Isolation And Retrieval Bag.
| Device ID | K931886 |
| 510k Number | K931886 |
| Device Name: | TISSUE ISOLATION AND RETRIEVAL BAG |
| Classification | Tape And Bandage, Adhesive |
| Applicant | ADVANCED SURGICAL, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Angelique Anderson |
| Correspondent | Angelique Anderson ADVANCED SURGICAL, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-15 |
| Decision Date | 1993-09-07 |