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FDA 510(k)

ZANLEX, ZAN-TEX & ZANDEX

K-Number: K830511 · 1983-03-17

ApplicantWinn Hirsch & Assoc.
Decision Date1983-03-17
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZANLEX, ZAN-TEX & ZANDEX is the device name listed in this FDA 510(k) record. The listed applicant is Winn Hirsch & Assoc.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K830511. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZANLEX, ZAN-TEX & ZANDEX?

ZANLEX, ZAN-TEX & ZANDEX is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Winn Hirsch & Assoc.. The 510(k) number is K830511.

When did ZANLEX, ZAN-TEX & ZANDEX receive FDA 510(k) clearance?

ZANLEX, ZAN-TEX & ZANDEX received FDA 510(k) clearance on 1983-03-17, under 510(k) number K830511.

Who is the listed applicant for ZANLEX, ZAN-TEX & ZANDEX?

The FDA 510(k) record lists Winn Hirsch & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZANLEX, ZAN-TEX & ZANDEX?

The FDA product code for ZANLEX, ZAN-TEX & ZANDEX is GDY.

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Other records listing Winn Hirsch & Assoc. 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.

K880309TYPE 316L STAINLESS STEEL WIREK864375TYPE 316L COTTER WIREK832214GAUZE CONVERSION CLASS I-NON-STERILEK832213GAUZE CONVERSION CLASS II STERILEK812390NEUROSPONGE PADDIEK812391NEUROSPONGES

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Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953059KITTNER DISSECTORMedical Perspectives Corp.

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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