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 |