The following data is part of a premarket notification filed by Medcare Custom Packaging, Inc. with the FDA for Single Use Instrument Tray.
| Device ID | K951149 |
| 510k Number | K951149 |
| Device Name: | SINGLE USE INSTRUMENT TRAY |
| Classification | General Surgery Tray |
| Applicant | MEDCARE CUSTOM PACKAGING, INC. 234 OLD HOMESTEAD HIGHWAY ROUTE 32 East Swanzey, NH 03446 |
| Contact | William A Hays |
| Correspondent | William A Hays MEDCARE CUSTOM PACKAGING, INC. 234 OLD HOMESTEAD HIGHWAY ROUTE 32 East Swanzey, NH 03446 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-13 |
| Decision Date | 1995-04-06 |