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FDA 510(k)

INSTANT HOT OR COLD DISPOSABLE PACK

K-Number: K935569 · 1994-03-07

ApplicantCryopak Industries, Inc.
Decision Date1994-03-07
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INSTANT HOT OR COLD DISPOSABLE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Cryopak Industries, Inc.. It received FDA 510(k) clearance on 1994-03-07 under 510(k) number K935569. 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 INSTANT HOT OR COLD DISPOSABLE PACK?

INSTANT HOT OR COLD DISPOSABLE PACK is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Cryopak Industries, Inc.. The 510(k) number is K935569.

When did INSTANT HOT OR COLD DISPOSABLE PACK receive FDA 510(k) clearance?

INSTANT HOT OR COLD DISPOSABLE PACK received FDA 510(k) clearance on 1994-03-07, under 510(k) number K935569.

Who is the listed applicant for INSTANT HOT OR COLD DISPOSABLE PACK?

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

What is the FDA product code for INSTANT HOT OR COLD DISPOSABLE PACK?

The FDA product code for INSTANT HOT OR COLD DISPOSABLE PACK is IMD.

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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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