The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture Disposable Endoscopic Specimen Pouch.
| Device ID | K922123 |
| 510k Number | K922123 |
| Device Name: | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH |
| Classification | Laryngoscope, Endoscope |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Nada Maric |
| Correspondent | Nada Maric UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GCI |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-06 |
| Decision Date | 1993-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884523000952 | K922123 | 000 |
| 20884523000945 | K922123 | 000 |