The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Prefilled Specimen Jars 10% Neutral Buf-formalin.
| Device ID | K853497 |
| 510k Number | K853497 |
| Device Name: | PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN |
| Classification | Formalin, Neutral Buffered |
| Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Contact | Ken Urban |
| Correspondent | Ken Urban SURGIPATH MEDICAL INDUSTRIES, INC. P.O. BOX 769 Grayslake, IL 60030 |
| Product Code | IFP |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-20 |
| Decision Date | 1985-08-28 |