The following data is part of a premarket notification filed by Wiggins Medical with the FDA for Wiggins Medical Surgical Instruments.
| Device ID | K200383 |
| 510k Number | K200383 |
| Device Name: | Wiggins Medical Surgical Instruments |
| Classification | Rongeur, Manual |
| Applicant | Wiggins Medical 2230 Park Avenue #202 Cincinnati, OH 45206 |
| Contact | Alex Ebner |
| Correspondent | Cassandra Petrov JALEX Medical 27865 Clemens Rd Suite 3 Westlake, OH 44145 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-18 |
| Decision Date | 2020-07-21 |
| Summary: | summary |