The following data is part of a premarket notification filed by Miele Professional with the FDA for Miele G 7781 Dental Thermal Disinfector.
Device ID | K950518 |
510k Number | K950518 |
Device Name: | MIELE G 7781 DENTAL THERMAL DISINFECTOR |
Classification | Device, Pasteurization, Hot Water |
Applicant | MIELE PROFESSIONAL 22 D WORLDS FAIR DR. Somerset, NJ 08852 |
Contact | Bernard Sessman |
Correspondent | Bernard Sessman MIELE PROFESSIONAL 22 D WORLDS FAIR DR. Somerset, NJ 08852 |
Product Code | LDS |
CFR Regulation Number | 880.6991 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-06 |
Decision Date | 1996-01-26 |