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 | K941500 |
| 510k Number | K941500 |
| Device Name: | TISSUE ISOLATION AND RETRIEVAL BAG |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ADVANCED SURGICAL, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Contact | Howard Shrayer |
| Correspondent | Howard Shrayer ADVANCED SURGICAL, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-29 |
| Decision Date | 1994-04-19 |