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FDA 510(k)

DELPORE SKIN CLOSURE

K-Number: K952947 · 1995-07-24

ApplicantBitco Intl.
Decision Date1995-07-24
Product CodeFPX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DELPORE SKIN CLOSURE is the device name listed in this FDA 510(k) record. The listed applicant is Bitco Intl.. It received FDA 510(k) clearance on 1995-07-24 under 510(k) number K952947. 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 DELPORE SKIN CLOSURE?

DELPORE SKIN CLOSURE is a medical device that received FDA 510(k) clearance on 1995-07-24. The listed applicant is Bitco Intl.. The 510(k) number is K952947.

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

DELPORE SKIN CLOSURE received FDA 510(k) clearance on 1995-07-24, under 510(k) number K952947.

Who is the listed applicant for DELPORE SKIN CLOSURE?

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

What is the FDA product code for DELPORE SKIN CLOSURE?

The FDA product code for DELPORE SKIN CLOSURE is FPX.

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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.K952702DERMA SEALTtl MedicalK946321BIOSTRIP STERILE WOUND CLOSURE STRIPCornelia Damsky, Inc.K931005DUKAL SKIN CLOSURE STRIPDukal Corp.K921775SPYROFLEX WOUND CLOSURESPolymint Industrial Co. , Ltd.K894802AWC BUTTERFLY WOUND CLOSURESAmerican White Cross, 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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