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FDA 510(k)

TECNOL CATHETER LEG STRAP

K-Number: K882641 · 1988-07-12

ApplicantTecnol New Jersey Wound Care, Inc.
Decision Date1988-07-12
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TECNOL CATHETER LEG STRAP is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol New Jersey Wound Care, Inc.. It received FDA 510(k) clearance on 1988-07-12 under 510(k) number K882641. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECNOL CATHETER LEG STRAP?

TECNOL CATHETER LEG STRAP is a medical device that received FDA 510(k) clearance on 1988-07-12. The listed applicant is Tecnol New Jersey Wound Care, Inc.. The 510(k) number is K882641.

When did TECNOL CATHETER LEG STRAP receive FDA 510(k) clearance?

TECNOL CATHETER LEG STRAP received FDA 510(k) clearance on 1988-07-12, under 510(k) number K882641.

Who is the listed applicant for TECNOL CATHETER LEG STRAP?

The FDA 510(k) record lists Tecnol New Jersey Wound Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECNOL CATHETER LEG STRAP?

The FDA product code for TECNOL CATHETER LEG STRAP is KNY.

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Other records listing Tecnol New Jersey Wound Care, Inc. 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.

K913043MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKSK911891FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASKK911907FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VISK896193TECNOL LAZER(TM) SURGICAL MASKK894205TECNOL SILK STRIPK893702TECNOL GAITERS PRODUCT NUMBER 47725-010

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Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

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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