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(r) Endoscopic Lds(tm) Ligating Device.
| Device ID | K905587 |
| 510k Number | K905587 |
| Device Name: | AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE |
| Classification | Clip, Implantable |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-13 |
| Decision Date | 1991-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521057593 | K905587 | 000 |