The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acuflex Levy Acl Drill Guide Sys.
| Device ID | K832277 |
| 510k Number | K832277 |
| Device Name: | ACUFLEX LEVY ACL DRILL GUIDE SYS |
| Classification | Arthroscope |
| Applicant | ACUFEX MICROSURGICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-12 |
| Decision Date | 1983-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556605332 | K832277 | 000 |
| 03596010610768 | K832277 | 000 |
| 03596010551306 | K832277 | 000 |
| 03596010441676 | K832277 | 000 |
| 03596010091499 | K832277 | 000 |
| 03596010091482 | K832277 | 000 |
| 03596010091475 | K832277 | 000 |
| 03596010091352 | K832277 | 000 |
| 03596010025159 | K832277 | 000 |
| 03596010025111 | K832277 | 000 |
| 03596010025104 | K832277 | 000 |
| 03596010025098 | K832277 | 000 |
| 03596010025081 | K832277 | 000 |
| 03596010590282 | K832277 | 000 |
| 03596010610775 | K832277 | 000 |
| 00885554000917 | K832277 | 000 |
| 00885556558768 | K832277 | 000 |
| 00885556605325 | K832277 | 000 |
| 00885556605134 | K832277 | 000 |
| 00885556605110 | K832277 | 000 |
| 00885556604809 | K832277 | 000 |
| 00885556604793 | K832277 | 000 |
| 00885556604779 | K832277 | 000 |
| 00885556604762 | K832277 | 000 |
| 00885556604755 | K832277 | 000 |
| 00885556604748 | K832277 | 000 |
| 00885556604625 | K832277 | 000 |
| 00885556604601 | K832277 | 000 |
| 00885556590584 | K832277 | 000 |
| 00885556558775 | K832277 | 000 |
| 03596010524133 | K832277 | 000 |