The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Proline Fast Pass Arthoscopic Needle Passer.
| Device ID | K961853 |
| 510k Number | K961853 |
| Device Name: | PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER |
| Classification | Arthroscope |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Susan A Finneran |
| Correspondent | Susan A Finneran 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 | 1996-05-14 |
| Decision Date | 1996-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556608616 | K961853 | 000 |