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FDA 510(k)

COLD PACK

K-Number: K780603 · 1978-04-21

ApplicantAbco Dealers, Inc.
Decision Date1978-04-21
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COLD PACK 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 1978-04-21 under 510(k) number K780603. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLD PACK?

COLD PACK is a medical device that received FDA 510(k) clearance on 1978-04-21. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K780603.

When did COLD PACK receive FDA 510(k) clearance?

COLD PACK received FDA 510(k) clearance on 1978-04-21, under 510(k) number K780603.

Who is the listed applicant for COLD PACK?

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 COLD PACK?

The FDA product code for COLD PACK is IMD.

Other records listing Abco Dealers, Inc. as applicant

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Related Devices (Code: IMD)

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.

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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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