The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for C-e Brush.
Device ID | K881921 |
510k Number | K881921 |
Device Name: | C-E BRUSH |
Classification | Spatula, Cervical, Cytological |
Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
Contact | Joy F Monek |
Correspondent | Joy F Monek SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
Product Code | HHT |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-09 |
Decision Date | 1988-07-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() C-E BRUSH 73765801 1547221 Live/Registered |
SURGIPATH MEDICAL INDUSTRIES, INC. 1988-11-25 |