The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Wiredriver.
Device ID | K772324 |
510k Number | K772324 |
Device Name: | WIREDRIVER |
Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
Applicant | AMERICAN STERILIZER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HSZ |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-19 |
Decision Date | 1978-01-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
WIREDRIVER 73544664 1379002 Dead/Cancelled |
CONTROLONICS CORPORATION 1985-06-24 |