The following data is part of a premarket notification filed by Citation Medical Corp. with the FDA for Citscope, Bendable -- Modification.
Device ID | K924494 |
510k Number | K924494 |
Device Name: | CITSCOPE, BENDABLE -- MODIFICATION |
Classification | Arthroscope |
Applicant | CITATION MEDICAL CORP. 230 EDISON WAY Reno, NV 89502 |
Contact | Edward F Waddell |
Correspondent | Edward F Waddell CITATION MEDICAL CORP. 230 EDISON WAY Reno, NV 89502 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-27 |
Decision Date | 1993-05-26 |