The following data is part of a premarket notification filed by Bowen & Company, Inc. with the FDA for Bowen Electrode Skin Prepatory Cleanser.
Device ID | K896898 |
510k Number | K896898 |
Device Name: | BOWEN ELECTRODE SKIN PREPATORY CLEANSER |
Classification | Pad, Alcohol, Device Disinfectant |
Applicant | BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
Contact | Pamela Gasper |
Correspondent | Pamela Gasper BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
Product Code | LKB |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-08 |
Decision Date | 1990-04-04 |