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FDA 510(k)

PAPCONE

K-Number: K083012 · 2009-04-09

ApplicantOtto Bock Pur Life Science GmbH
Decision Date2009-04-09
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PAPCONE is the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Pur Life Science GmbH. It received FDA 510(k) clearance on 2009-04-09 under 510(k) number K083012. 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 PAPCONE?

PAPCONE is a medical device that received FDA 510(k) clearance on 2009-04-09. The listed applicant is Otto Bock Pur Life Science GmbH. The 510(k) number is K083012.

When did PAPCONE receive FDA 510(k) clearance?

PAPCONE received FDA 510(k) clearance on 2009-04-09, under 510(k) number K083012.

Who is the listed applicant for PAPCONE?

The FDA 510(k) record lists Otto Bock Pur Life Science GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAPCONE?

The FDA product code for PAPCONE is HHT.

Related Clinical Trials

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.

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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, LLCK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGYBio Nuclear Diagnostics, Inc.K072381SOFTPAP CERVICAL CELL COLLECTORCytocore, Inc.K062433DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEMDiamics, Inc.

Official Source

View on FDA Database →

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

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