The following data is part of a premarket notification filed by Medcare Custom Packaging, Inc. with the FDA for Burn Dressing Tray.
| Device ID | K942000 |
| 510k Number | K942000 |
| Device Name: | BURN DRESSING TRAY |
| Classification | Wrap, Sterilization |
| Applicant | MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey, NH 03469 -0069 |
| Contact | William A Hays |
| Correspondent | William A Hays MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey, NH 03469 -0069 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-25 |
| Decision Date | 1994-05-20 |