The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Custom Procedure Tray.
| Device ID | K911565 |
| 510k Number | K911565 |
| Device Name: | CUSTOM PROCEDURE TRAY |
| Classification | Drape, Surgical |
| Applicant | VANGUARD MEDICAL CONCEPTS, INC. 3108 BRUTON RD. Plant City, FL 33565 |
| Contact | Chuck Masek |
| Correspondent | Chuck Masek VANGUARD MEDICAL CONCEPTS, INC. 3108 BRUTON RD. Plant City, FL 33565 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-09 |
| Decision Date | 1991-08-09 |