The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex(r) Endo-femoral Aimer.
| Device ID | K942846 |
| 510k Number | K942846 |
| Device Name: | ACUFEX(R) ENDO-FEMORAL AIMER |
| 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 | 1994-06-16 |
| Decision Date | 1994-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010601438 | K942846 | 000 |
| 03596010026446 | K942846 | 000 |
| 03596010026439 | K942846 | 000 |
| 03596010026422 | K942846 | 000 |
| 00885556558966 | K942846 | 000 |
| 00885556558959 | K942846 | 000 |
| 00885554001945 | K942846 | 000 |