The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Sed-fix Concentrate.
| Device ID | K852045 |
| 510k Number | K852045 |
| Device Name: | SED-FIX CONCENTRATE |
| Classification | Polyethylene Glycol (carbowax) |
| 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 | IER |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-09 |
| Decision Date | 1985-06-10 |