The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Ultrasonic Hand Instruments.
| Device ID | K971861 |
| 510k Number | K971861 |
| Device Name: | ULTRASONIC HAND INSTRUMENTS |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Victor Clavelli |
| Correspondent | Victor Clavelli UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-20 |
| Decision Date | 1997-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521058313 | K971861 | 000 |
| 20884521058160 | K971861 | 000 |
| 10884521058231 | K971861 | 000 |
| 10884521058330 | K971861 | 000 |
| 20884521058344 | K971861 | 000 |
| 10884521058187 | K971861 | 000 |
| 10884521058194 | K971861 | 000 |
| 20884521058276 | K971861 | 000 |
| 20884521058306 | K971861 | 000 |
| 10884521058200 | K971861 | 000 |