The following data is part of a premarket notification filed by Union Broach, Div. Moyco Industries, Inc. with the FDA for Moyco-edta.
Device ID | K950365 |
510k Number | K950365 |
Device Name: | MOYCO-EDTA |
Classification | Cleanser, Root Canal |
Applicant | UNION BROACH, DIV. MOYCO INDUSTRIES, INC. DIVISION OF MOYCO IND., INC. P.O. BOX 508, ABERDEEN ROAD Emigsville, PA 17318 |
Contact | Chris M Lehr |
Correspondent | Chris M Lehr UNION BROACH, DIV. MOYCO INDUSTRIES, INC. DIVISION OF MOYCO IND., INC. P.O. BOX 508, ABERDEEN ROAD Emigsville, PA 17318 |
Product Code | KJJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-31 |
Decision Date | 1995-04-27 |