The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Surgical Kit-acufex Mosaicplasty System.
| Device ID | K962789 |
| 510k Number | K962789 |
| Device Name: | SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Tedd Gosian |
| Correspondent | Tedd Gosian SMITH & NEPHEW ENDOSCOPY, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-17 |
| Decision Date | 1996-08-14 |
| Summary: | summary |