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FDA 510(k)

INCARE HOT/ICE LITE MACHINE

K-Number: K962537 · 1996-11-27

ApplicantHollister, Inc.
Decision Date1996-11-27
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INCARE HOT/ICE LITE MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1996-11-27 under 510(k) number K962537. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCARE HOT/ICE LITE MACHINE?

INCARE HOT/ICE LITE MACHINE is a medical device that received FDA 510(k) clearance on 1996-11-27. The listed applicant is Hollister, Inc.. The 510(k) number is K962537.

When did INCARE HOT/ICE LITE MACHINE receive FDA 510(k) clearance?

INCARE HOT/ICE LITE MACHINE received FDA 510(k) clearance on 1996-11-27, under 510(k) number K962537.

Who is the listed applicant for INCARE HOT/ICE LITE MACHINE?

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 LITE MACHINE?

The FDA product code for INCARE HOT/ICE LITE MACHINE 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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