The following data is part of a premarket notification filed by Medcare Custom Packaging, Inc. with the FDA for Custom Wound Management Kits And Trays.
| Device ID | K901856 |
| 510k Number | K901856 |
| Device Name: | CUSTOM WOUND MANAGEMENT KITS AND TRAYS |
| Classification | General Surgery Tray |
| Applicant | MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey, NH 03469 -0069 |
| Contact | David B Peters |
| Correspondent | David B Peters MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey, NH 03469 -0069 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-24 |
| Decision Date | 1990-08-01 |