The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Endobutton Tape.
| Device ID | K952535 |
| 510k Number | K952535 |
| Device Name: | ACUFEX ENDOBUTTON TAPE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-01 |
| Decision Date | 1996-02-08 |