The following data is part of a premarket notification filed by Sunrise Technologies, Inc. with the FDA for Microprep Cavity Preperation System.
Device ID | K932997 |
510k Number | K932997 |
Device Name: | MICROPREP CAVITY PREPERATION SYSTEM |
Classification | Airbrush |
Applicant | SUNRISE TECHNOLOGIES, INC. 47257 FREMONT BLVD. Fremont, CA 94538 |
Contact | Charles Rose |
Correspondent | Charles Rose SUNRISE TECHNOLOGIES, INC. 47257 FREMONT BLVD. Fremont, CA 94538 |
Product Code | KOJ |
CFR Regulation Number | 872.6080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-18 |
Decision Date | 1994-04-25 |