The following data is part of a premarket notification filed by Citation Medical Corp. with the FDA for Citation Power Tool.
Device ID | K946290 |
510k Number | K946290 |
Device Name: | CITATION POWER TOOL |
Classification | Arthroscope |
Applicant | CITATION MEDICAL CORP. 230 EDISON WAY Reno, NV 89502 |
Contact | Roger Krieidberg |
Correspondent | Roger Krieidberg CITATION MEDICAL CORP. 230 EDISON WAY Reno, NV 89502 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-27 |
Decision Date | 1995-06-15 |