The following data is part of a premarket notification filed by Medical Custom Products, Inc. with the FDA for Custom Procedure Trays.
| Device ID | K871616 |
| 510k Number | K871616 |
| Device Name: | CUSTOM PROCEDURE TRAYS |
| Classification | Syringe, Piston |
| Applicant | MEDICAL CUSTOM PRODUCTS, INC. 246 DODGE AVE. P.O. BOX 567 East Haven, CT 06512 |
| Contact | Dorsie W Marcum |
| Correspondent | Dorsie W Marcum MEDICAL CUSTOM PRODUCTS, INC. 246 DODGE AVE. P.O. BOX 567 East Haven, CT 06512 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-27 |
| Decision Date | 1987-12-11 |