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FDA 510(k)

SOFTPAP CERVICAL CELL COLLECTOR

K-Number: K072381 · 2008-01-30

ApplicantCytocore, Inc.
Decision Date2008-01-30
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SOFTPAP CERVICAL CELL COLLECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Cytocore, Inc.. It received FDA 510(k) clearance on 2008-01-30 under 510(k) number K072381. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFTPAP CERVICAL CELL COLLECTOR?

SOFTPAP CERVICAL CELL COLLECTOR is a medical device that received FDA 510(k) clearance on 2008-01-30. The listed applicant is Cytocore, Inc.. The 510(k) number is K072381.

When did SOFTPAP CERVICAL CELL COLLECTOR receive FDA 510(k) clearance?

SOFTPAP CERVICAL CELL COLLECTOR received FDA 510(k) clearance on 2008-01-30, under 510(k) number K072381.

Who is the listed applicant for SOFTPAP CERVICAL CELL COLLECTOR?

The FDA 510(k) record lists Cytocore, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFTPAP CERVICAL CELL COLLECTOR?

The FDA product code for SOFTPAP CERVICAL CELL COLLECTOR is HHT.

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Related Devices (Code: HHT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182049exCellerator Cervical Collection DeviceExcell Company, LLCK153128Kolplast Cervical Sample Collection KitKolplast CI SAK111681HISTOBRUSHPuritan Medical Products Company, LLCK083012PAPCONEOtto Bock Pur Life Science GmbHK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K062433DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEMDiamics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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