The following data is part of a premarket notification filed by Medcare Medical Group, Inc. with the FDA for Single Use Instrument Tray.
| Device ID | K962328 |
| 510k Number | K962328 |
| Device Name: | SINGLE USE INSTRUMENT TRAY |
| Classification | Tray, Surgical, Instrument |
| Applicant | MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
| Contact | Craig J Bell |
| Correspondent | Craig J Bell MEDCARE MEDICAL GROUP, INC. 234 OLD HOMESTEAD HWY. East Swanzey, NH 03446 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-06 |
| Decision Date | 1996-08-09 |