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FDA 510(k)

DUKAL SKIN CLOSURE STRIP

K-Number: K931005 · 1993-07-14

ApplicantDukal Corp.
Decision Date1993-07-14
Product CodeFPX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUKAL SKIN CLOSURE STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Dukal Corp.. It received FDA 510(k) clearance on 1993-07-14 under 510(k) number K931005. 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 DUKAL SKIN CLOSURE STRIP?

DUKAL SKIN CLOSURE STRIP is a medical device that received FDA 510(k) clearance on 1993-07-14. The listed applicant is Dukal Corp.. The 510(k) number is K931005.

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

DUKAL SKIN CLOSURE STRIP received FDA 510(k) clearance on 1993-07-14, under 510(k) number K931005.

Who is the listed applicant for DUKAL SKIN CLOSURE STRIP?

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

What is the FDA product code for DUKAL SKIN CLOSURE STRIP?

The FDA product code for DUKAL SKIN CLOSURE STRIP is FPX.

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Other records listing Dukal 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.

K083320DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPEK070407DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUEK061864DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560K020726DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGEK984564ETHYL CHLORIDE DISPENSERK970457DUKAL ABD COMBINE PAD

View all 11 devices →

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.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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