The following data is part of a premarket notification filed by Moyco Industries, Inc. with the FDA for Silicone Mirror.
Device ID | K932511 |
510k Number | K932511 |
Device Name: | SILICONE MIRROR |
Classification | Burnisher, Operative |
Applicant | MOYCO INDUSTRIES, INC. 2054 WEST CLEARFIELD ST. PHILADELPHIA, PA 19132 -1516 |
Contact | CHRIS M LEHR |
Correspondent | CHRIS M LEHR MOYCO INDUSTRIES, INC. 2054 WEST CLEARFIELD ST. PHILADELPHIA, PA 19132 -1516 |
Product Code | EKJ |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-25 |
Decision Date | 1993-11-05 |