The following data is part of a premarket notification filed by Miele Appliances, Inc. with the FDA for Model G7731d Washer/disinfector For Dental Instru..
Device ID | K884151 |
510k Number | K884151 |
Device Name: | MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. |
Classification | Device, Pasteurization, Hot Water |
Applicant | MIELE APPLIANCES, INC. 22D WORLDS FAIR DR. Somerset, NJ 08873 |
Contact | Denis J O'brien |
Correspondent | Denis J O'brien MIELE APPLIANCES, INC. 22D WORLDS FAIR DR. Somerset, NJ 08873 |
Product Code | LDS |
CFR Regulation Number | 880.6991 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-03 |
Decision Date | 1989-05-16 |