The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Pro-pac And Iso-pac.
| Device ID | K931621 |
| 510k Number | K931621 |
| Device Name: | ACUFEX PRO-PAC AND ISO-PAC |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-02 |
| Decision Date | 1994-01-21 |