The following data is part of a premarket notification filed by Medical Action Industries, Inc. with the FDA for Spatula, Cervical, Cytological, Model 22-9107.
| Device ID | K042527 |
| 510k Number | K042527 |
| Device Name: | SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 |
| Classification | Spatula, Cervical, Cytological |
| Applicant | MEDICAL ACTION INDUSTRIES, INC. 25 HEYWOOD RD. Arden, NC 28704 |
| Contact | Robin Blankenbaker |
| Correspondent | Robin Blankenbaker MEDICAL ACTION INDUSTRIES, INC. 25 HEYWOOD RD. Arden, NC 28704 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-17 |
| Decision Date | 2004-11-08 |