The following data is part of a premarket notification filed by Medcare Medical Group, Inc. with the FDA for General Purpose Dental Tray.
| Device ID | K962527 |
| 510k Number | K962527 |
| Device Name: | GENERAL PURPOSE DENTAL TRAY |
| Classification | Unit, Operative Dental |
| 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 | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-27 |
| Decision Date | 1996-08-01 |
| Summary: | summary |