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FDA 510(k)

SUTURELESS SKIN CLOSURE

K-Number: K780565 · 1978-07-07

ApplicantAbbott Laboratories
Decision Date1978-07-07
Product CodeFPX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUTURELESS SKIN CLOSURE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1978-07-07 under 510(k) number K780565. 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 SUTURELESS SKIN CLOSURE?

SUTURELESS SKIN CLOSURE is a medical device that received FDA 510(k) clearance on 1978-07-07. The listed applicant is Abbott Laboratories. The 510(k) number is K780565.

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

SUTURELESS SKIN CLOSURE received FDA 510(k) clearance on 1978-07-07, under 510(k) number K780565.

Who is the listed applicant for SUTURELESS SKIN CLOSURE?

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

What is the FDA product code for SUTURELESS SKIN CLOSURE?

The FDA product code for SUTURELESS 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.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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