The following data is part of a premarket notification filed by Protector, Inc. with the FDA for Explorer, Operative.
Device ID | K925888 |
510k Number | K925888 |
Device Name: | EXPLORER, OPERATIVE |
Classification | Burnisher, Operative |
Applicant | PROTECTOR, INC. C/O ASIAN PACIFIC IMPORTS P.O. BOX 92195 Long Beach, CA 90809 |
Contact | Michael W Guenther |
Correspondent | Michael W Guenther PROTECTOR, INC. C/O ASIAN PACIFIC IMPORTS P.O. BOX 92195 Long Beach, CA 90809 |
Product Code | EKJ |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-16 |
Decision Date | 1994-02-15 |