The following data is part of a premarket notification filed by Citation Medical Corp. with the FDA for Citscope (model Extensions).
| Device ID | K922144 |
| 510k Number | K922144 |
| Device Name: | CITSCOPE (MODEL EXTENSIONS) |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-06 |
| Decision Date | 1992-08-05 |