The following data is part of a premarket notification filed by General Medical Co. with the FDA for Procedure Kit.
| Device ID | K926269 |
| 510k Number | K926269 |
| Device Name: | PROCEDURE KIT |
| Classification | General Surgery Tray |
| Applicant | GENERAL MEDICAL CO. 8741 LANDMARK RD. P.O. BOX 27452 Richmond, VA 23261 |
| Contact | Alfred H Grebe |
| Correspondent | Alfred H Grebe GENERAL MEDICAL CO. 8741 LANDMARK RD. P.O. BOX 27452 Richmond, VA 23261 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-18 |
| Decision Date | 1993-08-27 |