The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Surgi-pap Kit.
| Device ID | K850676 |
| 510k Number | K850676 |
| Device Name: | SURGI-PAP KIT |
| 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 | 1985-02-21 |
| Decision Date | 1985-03-22 |