The following data is part of a premarket notification filed by Minnesota Prophy Power, Inc. with the FDA for Dental Instruments Scaler.
Device ID | K931330 |
510k Number | K931330 |
Device Name: | DENTAL INSTRUMENTS SCALER |
Classification | Scaler, Periodontic |
Applicant | MINNESOTA PROPHY POWER, INC. 11538 172ND ST. Lakeville, MN 55044 |
Contact | Roselyn R Wilson |
Correspondent | Roselyn R Wilson MINNESOTA PROPHY POWER, INC. 11538 172ND ST. Lakeville, MN 55044 |
Product Code | EMN |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-16 |
Decision Date | 1994-01-26 |