The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex(r) Arthroplasty Instruments.
| Device ID | K940985 |
| 510k Number | K940985 |
| Device Name: | ACUFEX(R) ARTHROPLASTY INSTRUMENTS |
| 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 | 1994-03-01 |
| Decision Date | 1994-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556604441 | K940985 | 000 |
| 03596010091178 | K940985 | 000 |
| 03596010091161 | K940985 | 000 |
| 03596010080943 | K940985 | 000 |
| 03596010080936 | K940985 | 000 |
| 03596010080912 | K940985 | 000 |
| 03596010080875 | K940985 | 000 |
| 03596010080783 | K940985 | 000 |
| 03596010080653 | K940985 | 000 |
| 03596010080479 | K940985 | 000 |
| 03596010026781 | K940985 | 000 |
| 03596010026736 | K940985 | 000 |
| 03596010026408 | K940985 | 000 |
| 03596010026347 | K940985 | 000 |
| 03596010026330 | K940985 | 000 |
| 03596010026323 | K940985 | 000 |
| 03596010026316 | K940985 | 000 |
| 03596010091185 | K940985 | 000 |
| 03596010091192 | K940985 | 000 |
| 03596010441874 | K940985 | 000 |
| 00885556604434 | K940985 | 000 |
| 00885556604427 | K940985 | 000 |
| 00885556604410 | K940985 | 000 |
| 00885556604403 | K940985 | 000 |
| 00885556604397 | K940985 | 000 |
| 00885556558669 | K940985 | 000 |
| 03596010080929 | K940985 | 000 |
| 03596010080899 | K940985 | 000 |
| 03596010080592 | K940985 | 000 |
| 03596010080530 | K940985 | 000 |
| 03596010026729 | K940985 | 000 |
| 03596010026712 | K940985 | 000 |
| 03596010025289 | K940985 | 000 |
| 03596010025272 | K940985 | 000 |
| 03596010025258 | K940985 | 000 |
| 03596010446220 | K940985 | 000 |
| 03596010025241 | K940985 | 000 |