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FDA 510(k)

EYE PADS CAT.#581-599

K-Number: K801995 · 1980-09-09

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

Device Summary

EYE PADS CAT.#581-599 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 1980-09-09 under 510(k) number K801995. The device is classified under product code HMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE PADS CAT.#581-599?

EYE PADS CAT.#581-599 is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Pollak (Intl.), Ltd.. The 510(k) number is K801995.

When did EYE PADS CAT.#581-599 receive FDA 510(k) clearance?

EYE PADS CAT.#581-599 received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801995.

Who is the listed applicant for EYE PADS CAT.#581-599?

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 EYE PADS CAT.#581-599?

The FDA product code for EYE PADS CAT.#581-599 is HMP.

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: HMP)

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.

K940333EYE PADCertified Safety Mfg., Inc.K921349STERILE,DISPOSABLE EYE DRESSINGDeroyal Industries, Inc.K904896EYE PADUlti-Med Intl., Inc.K883822FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309Consolidated Industries of Greater Syracuse, Inc.K874411DONALDSON NATURAL EYEPATCH 'PATIENT PAK'Keeler Instruments, Inc.K864810LIDSPLINTPrecision Therapeutics, 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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