The following data is part of a premarket notification filed by Citation Medical Corp. with the FDA for Citation Delta Scope.
| Device ID | K945390 |
| 510k Number | K945390 |
| Device Name: | CITATION DELTA SCOPE |
| Classification | Arthroscope |
| Applicant | CITATION MEDICAL CORP. 230 EDISON WAY Reno, NV 89502 |
| Contact | Roger Kreiberg |
| Correspondent | Roger Kreiberg 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 | 1994-11-03 |
| Decision Date | 1995-06-23 |