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) Modified Endoscopic Ligating Loop.
| Device ID | K904588 |
| 510k Number | K904588 |
| Device Name: | AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP |
| Classification | Suture, Absorbable, Natural |
| 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 | GAL |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-26 |
| Decision Date | 1990-12-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521099623 | K904588 | 000 |
| 20884521099668 | K904588 | 000 |
| 20884521099651 | K904588 | 000 |
| 20884521099644 | K904588 | 000 |
| 20884521099637 | K904588 | 000 |
| 20884521099545 | K904588 | 000 |
| 20884521099538 | K904588 | 000 |
| 20884521099521 | K904588 | 000 |
| 20884521099460 | K904588 | 000 |