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FDA 510(k)

DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404

K-Number: K101276 · 2010-07-28

ApplicantChemence Medical Products, Inc.
Decision Date2010-07-28
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 is the device name listed in this FDA 510(k) record. The listed applicant is Chemence Medical Products, Inc.. It received FDA 510(k) clearance on 2010-07-28 under 510(k) number K101276. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404?

DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 is a medical device that received FDA 510(k) clearance on 2010-07-28. The listed applicant is Chemence Medical Products, Inc.. The 510(k) number is K101276.

When did DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 receive FDA 510(k) clearance?

DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 received FDA 510(k) clearance on 2010-07-28, under 510(k) number K101276.

Who is the listed applicant for DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404?

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

What is the FDA product code for DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404?

The FDA product code for DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 is MPN.

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Other records listing Chemence Medical Products, Inc. as applicant

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Related Devices (Code: MPN)

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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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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