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 |