The following data is part of a premarket notification filed by Smith & Nephew Endoscopy, Inc. with the FDA for Acufex Mosaicplasty Comprehensive System.
| Device ID | K964215 |
| 510k Number | K964215 |
| Device Name: | ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-22 |
| Decision Date | 1996-12-20 |
| Summary: | summary |