Cyto Pak Pap Smear Kit

FDA 510(k) K923143 · International Medical Equipment Brokers, Inc.

Unknown

510(k) numberK923143

Submission

Device name
Cyto Pak Pap Smear Kit
Applicant
International Medical Equipment Brokers, Inc.
Carlsbad, CA, US
Received
June 29, 1992
Decision date
July 16, 1993
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HHT – Spatula, Cervical, Cytological
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

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K072381Softpap Cervical Cell CollectorHHT · Special Cytocore, Inc.01/30/2008SE
K062433Diamics Cercol Cervical Sample Collector SystemHHT · Traditional Diamics, Inc.03/16/2007SE
K043369Cervex-Brush CombiHHT · Traditional Rovers Medical Devices B.V.02/02/2005SE
K042527Spatula, Cervical, Cytological, Model 22-9107HHT · Traditional Medical Action Industries, Inc.11/08/2004SE

Questions and answers

When was Cyto Pak Pap Smear Kit cleared by the FDA?

Cyto Pak Pap Smear Kit (K923143) received a 510(k) decision of Unknown on July 16, 1993, 382 days after the submission was received.

What is the product code of K923143?

The FDA product code is HHT – Spatula, Cervical, Cytological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.