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FDA 510(k)

INCARE HOT/ICE COLD THERAPY COOLER

K-Number: K944971 · 1995-01-30

ApplicantHollister, Inc.
Decision Date1995-01-30
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

INCARE HOT/ICE COLD THERAPY COOLER is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1995-01-30 under 510(k) number K944971. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the INCARE HOT/ICE COLD THERAPY COOLER?

INCARE HOT/ICE COLD THERAPY COOLER is a medical device that received FDA 510(k) clearance on 1995-01-30. The listed applicant is Hollister, Inc.. The 510(k) number is K944971.

When did INCARE HOT/ICE COLD THERAPY COOLER receive FDA 510(k) clearance?

INCARE HOT/ICE COLD THERAPY COOLER received FDA 510(k) clearance on 1995-01-30, under 510(k) number K944971.

Who is the listed applicant for INCARE HOT/ICE COLD THERAPY COOLER?

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

What is the FDA product code for INCARE HOT/ICE COLD THERAPY COOLER?

The FDA product code for INCARE HOT/ICE COLD THERAPY COOLER is ILO.

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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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