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FDA 510(k)

SKIN CLOSURE

K-Number: K840945 · 1984-10-31

ApplicantGainor Medical
Decision Date1984-10-31
Product CodeFPX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SKIN CLOSURE is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical. It received FDA 510(k) clearance on 1984-10-31 under 510(k) number K840945. The device is classified under product code FPX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIN CLOSURE?

SKIN CLOSURE is a medical device that received FDA 510(k) clearance on 1984-10-31. The listed applicant is Gainor Medical. The 510(k) number is K840945.

When did SKIN CLOSURE receive FDA 510(k) clearance?

SKIN CLOSURE received FDA 510(k) clearance on 1984-10-31, under 510(k) number K840945.

Who is the listed applicant for SKIN CLOSURE?

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

What is the FDA product code for SKIN CLOSURE?

The FDA product code for SKIN CLOSURE is FPX.

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Other records listing Gainor Medical as applicant

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.

K850100BLOOD LANCETK850150ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MEDK844306GAINOR MEDICAL SYRINGEK844305GAINOR MEDICAL FLOWMAX NEEDLESK840950ZINC OXIDE TAPEK840951FIRST AID BANDAGE

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Related Devices (Code: FPX)

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.

K970441K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTHMedi-Flex Hospital Products, Inc.K952947DELPORE SKIN CLOSUREBitco Intl.K952702DERMA SEALTtl MedicalK946321BIOSTRIP STERILE WOUND CLOSURE STRIPCornelia Damsky, Inc.K931005DUKAL SKIN CLOSURE STRIPDukal Corp.K921775SPYROFLEX WOUND CLOSURESPolymint Industrial Co. , Ltd.

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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