The following data is part of a premarket notification filed by Tridak Division Of Indicon, Inc. with the FDA for Cytological Cervical Spatula The Multi-spatula.
| Device ID | K851934 |
| 510k Number | K851934 |
| Device Name: | CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA |
| Classification | Spatula, Cervical, Cytological |
| Applicant | TRIDAK DIVISION OF INDICON, INC. ONE BLUE HILL PLAZA SUITE 815 Pearl River, NY 10965 |
| Contact | Corinne M Ambrosino |
| Correspondent | Corinne M Ambrosino TRIDAK DIVISION OF INDICON, INC. ONE BLUE HILL PLAZA SUITE 815 Pearl River, NY 10965 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-06 |
| Decision Date | 1985-07-05 |