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FDA 510(k)

DERMA STRIP-TM SKIN CLOSURES

K-Number: K833083 · 1983-12-30

ApplicantHowmedica Corp.
Decision Date1983-12-30
Product CodeFPX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMA STRIP-TM SKIN CLOSURES is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1983-12-30 under 510(k) number K833083. 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 DERMA STRIP-TM SKIN CLOSURES?

DERMA STRIP-TM SKIN CLOSURES is a medical device that received FDA 510(k) clearance on 1983-12-30. The listed applicant is Howmedica Corp.. The 510(k) number is K833083.

When did DERMA STRIP-TM SKIN CLOSURES receive FDA 510(k) clearance?

DERMA STRIP-TM SKIN CLOSURES received FDA 510(k) clearance on 1983-12-30, under 510(k) number K833083.

Who is the listed applicant for DERMA STRIP-TM SKIN CLOSURES?

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

What is the FDA product code for DERMA STRIP-TM SKIN CLOSURES?

The FDA product code for DERMA STRIP-TM SKIN CLOSURES is FPX.

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Other records listing Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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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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