FDA 510(k)

SPYROFLEX WOUND CLOSURES

K-Number: K921775 · 1992-05-19

Decision Date1992-05-19

Product CodeFPX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SPYROFLEX WOUND CLOSURES is the device name listed in this FDA 510(k) record. The listed applicant is Polymint Industrial Co. , Ltd.. It received FDA 510(k) clearance on 1992-05-19 under 510(k) number K921775. 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 SPYROFLEX WOUND CLOSURES?

SPYROFLEX WOUND CLOSURES is a medical device that received FDA 510(k) clearance on 1992-05-19. The listed applicant is Polymint Industrial Co. , Ltd.. The 510(k) number is K921775.

When did SPYROFLEX WOUND CLOSURES receive FDA 510(k) clearance?

SPYROFLEX WOUND CLOSURES received FDA 510(k) clearance on 1992-05-19, under 510(k) number K921775.

Who is the listed applicant for SPYROFLEX WOUND CLOSURES?

The FDA 510(k) record lists Polymint Industrial Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPYROFLEX WOUND CLOSURES?

The FDA product code for SPYROFLEX WOUND CLOSURES is FPX.

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Other records listing Polymint Industrial Co. , Ltd. as applicant

K932457SPYROGEL WOUND DRESSING K931634VARIOUS KITS K911649MITRASHEER TRANSPLANT DRESSING K891644SAMBORD LATEX PATIENT EXAMINATION GLOVES

Related Devices (Code: FPX)

K970441K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTHMedi-Flex Hospital Products, Inc.K952947DELPORE SKIN CLOSUREBitco Intl.K952702DERMA SEALTtl Medical K946321BIOSTRIP STERILE WOUND CLOSURE STRIPCornelia Damsky, Inc.K931005DUKAL SKIN CLOSURE STRIPDukal Corp.K894802AWC BUTTERFLY WOUND CLOSURESAmerican White Cross, Inc.

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.