The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Universal Cannula.
| Device ID | K830719 |
| 510k Number | K830719 |
| Device Name: | UNIVERSAL CANNULA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ACUFEX MICROSURGICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-08 |
| Decision Date | 1983-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010430311 | K830719 | 000 |
| 03596010078919 | K830719 | 000 |
| 03596010078872 | K830719 | 000 |
| 03596010078810 | K830719 | 000 |
| 03596010078759 | K830719 | 000 |
| 03596010078742 | K830719 | 000 |