The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Sprayfix.
Device ID | K850916 |
510k Number | K850916 |
Device Name: | SPRAYFIX |
Classification | General Purpose Reagent |
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 | PPM |
CFR Regulation Number | 864.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-05 |
Decision Date | 1985-03-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SPRAYFIX 73545289 1374448 Live/Registered |
SURGIPATH MEDICAL INDUSTRIES, INC. 1985-06-27 |