The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Endobutton System.
| Device ID | K933948 |
| 510k Number | K933948 |
| Device Name: | ACUFEX ENDOBUTTON SYSTEM |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Frederick Tobia |
| Correspondent | Frederick Tobia ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-12 |
| Decision Date | 1994-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556529423 | K933948 | 000 |
| 00885556529416 | K933948 | 000 |
| 03596010024763 | K933948 | 000 |