The following data is part of a premarket notification filed by Citation Medical Corp. with the FDA for Citation Medical Scope Procedure Pack.
| Device ID | K912490 |
| 510k Number | K912490 |
| Device Name: | CITATION MEDICAL SCOPE PROCEDURE PACK |
| Classification | Drape, Surgical |
| 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 | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-04 |
| Decision Date | 1991-08-16 |