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FDA 510(k)

PEDIBAND CAT.#195-197

K-Number: K802021 · 1980-09-16

ApplicantPollak (Intl.), Ltd.
Decision Date1980-09-16
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PEDIBAND CAT.#195-197 is the device name listed in this FDA 510(k) record. The listed applicant is Pollak (Intl.), Ltd.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K802021. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIBAND CAT.#195-197?

PEDIBAND CAT.#195-197 is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Pollak (Intl.), Ltd.. The 510(k) number is K802021.

When did PEDIBAND CAT.#195-197 receive FDA 510(k) clearance?

PEDIBAND CAT.#195-197 received FDA 510(k) clearance on 1980-09-16, under 510(k) number K802021.

Who is the listed applicant for PEDIBAND CAT.#195-197?

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

What is the FDA product code for PEDIBAND CAT.#195-197?

The FDA product code for PEDIBAND CAT.#195-197 is NAD.

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Other records listing Pollak (Intl.), Ltd. 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.

K000227UMBICUTK810049PEDICAT*K810050VECAFIX*K802011INFUSSION ALARM SYSTEM I.A.S. CAT.#1118K802009FLOWCLAMP CAT.#1011 & 1012K802017DRESSING CHANGE SET CAT.#910-930

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Related Devices (Code: NAD)

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.

K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALSam Medical ProductsK091133APLION TOPICAL CARE SYSTEMAplion Medical,LlcK072560ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)Teikoku Pharma USA, Inc.K080524CENTURION SORBAVIEW OTCTri-State Hospital Supply Corp.K060046DERMASTREAMEnzysurge , 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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