The following data is part of a premarket notification filed by International Medical Equipment Brokers, Inc. with the FDA for Cyto Pak Pap Smear Kit.
| Device ID | K923143 |
| 510k Number | K923143 |
| Device Name: | CYTO PAK PAP SMEAR KIT |
| Classification | Spatula, Cervical, Cytological |
| Applicant | INTERNATIONAL MEDICAL EQUIPMENT BROKERS, INC. 6451 EL CAMINO REAL SUITE A Carlsbad, CA 92009 |
| Contact | Deborah Krueger |
| Correspondent | Deborah Krueger INTERNATIONAL MEDICAL EQUIPMENT BROKERS, INC. 6451 EL CAMINO REAL SUITE A Carlsbad, CA 92009 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-29 |
| Decision Date | 1993-07-16 |