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FDA 510(k)

ICE BAG, VINYL

K-Number: K780608 · 1978-06-06

ApplicantAbco Dealers, Inc.
Decision Date1978-06-06
Product CodeKYR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ICE BAG, VINYL is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1978-06-06 under 510(k) number K780608. The device is classified under product code KYR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICE BAG, VINYL?

ICE BAG, VINYL is a medical device that received FDA 510(k) clearance on 1978-06-06. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K780608.

When did ICE BAG, VINYL receive FDA 510(k) clearance?

ICE BAG, VINYL received FDA 510(k) clearance on 1978-06-06, under 510(k) number K780608.

Who is the listed applicant for ICE BAG, VINYL?

The FDA 510(k) record lists Abco Dealers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICE BAG, VINYL?

The FDA product code for ICE BAG, VINYL is KYR.

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Other records listing Abco Dealers, 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.

K905025DIGITAL THERMOMETER KITSK882304DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)K880892BLOOD COLLECTING NEEDLE AND HOLDERSK880894ALLERGIST SYRINGESK872875STRETCH GAUZE BANDAGESK872874MICROSCOPE COVER GLASSES

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Related Devices (Code: KYR)

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.

K833872SAV-A-LIMBSil-Med Corp.K810653VINYL ICE BAGFirst Industries, Inc.K760951DEVON COOL FACEDevon Industries, 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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