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 |