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 |