The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Metal Acl Cannula.
| Device ID | K932718 |
| 510k Number | K932718 |
| Device Name: | ACUFEX METAL ACL CANNULA |
| Classification | Arthroscope |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson 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 | 1993-06-04 |
| Decision Date | 1994-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010381583 | K932718 | 000 |
| 03596010381576 | K932718 | 000 |
| 03596010026071 | K932718 | 000 |
| 03596010026057 | K932718 | 000 |
| 00885554000948 | K932718 | 000 |