The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Cervical Spatula.
| Device ID | K811548 |
| 510k Number | K811548 |
| Device Name: | CERVICAL SPATULA |
| Classification | Spatula, Cervical, Cytological |
| Applicant | PROCEDURE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-01 |
| Decision Date | 1981-06-23 |