The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Cuto(tm) Tissue Morcellation System.
| Device ID | K932700 |
| 510k Number | K932700 |
| Device Name: | CUTO(TM) TISSUE MORCELLATION SYSTEM |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Martha C Miller |
| Correspondent | Keith M Smith CONMED CORPORATION 525 FRENCH ROAD Utica, NY 13502 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-03 |
| Decision Date | 1993-10-15 |