The following data is part of a premarket notification filed by E.h. Medical Co. with the FDA for Bovo Moisture Guard.
Device ID | K850988 |
510k Number | K850988 |
Device Name: | BOVO MOISTURE GUARD |
Classification | Absorber, Saliva, Paper |
Applicant | E.H. MEDICAL CO. BROWN, MARTIN & HALLER 110 W. C STREET - 13TH. FLOOR San Diego, CA 92101 |
Contact | Neil F Martin |
Correspondent | Neil F Martin E.H. MEDICAL CO. BROWN, MARTIN & HALLER 110 W. C STREET - 13TH. FLOOR San Diego, CA 92101 |
Product Code | KHR |
CFR Regulation Number | 872.6050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-11 |
Decision Date | 1985-04-16 |