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FDA 510(k)

RESTORE, THERMACELLS (HOT PACK I)

K-Number: K953442 · 1995-10-31

ApplicantNeal Dunning Assoc., Inc.
Decision Date1995-10-31
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

RESTORE, THERMACELLS (HOT PACK I) is the device name listed in this FDA 510(k) record. The listed applicant is Neal Dunning Assoc., Inc.. It received FDA 510(k) clearance on 1995-10-31 under 510(k) number K953442. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the RESTORE, THERMACELLS (HOT PACK I)?

RESTORE, THERMACELLS (HOT PACK I) is a medical device that received FDA 510(k) clearance on 1995-10-31. The listed applicant is Neal Dunning Assoc., Inc.. The 510(k) number is K953442.

When did RESTORE, THERMACELLS (HOT PACK I) receive FDA 510(k) clearance?

RESTORE, THERMACELLS (HOT PACK I) received FDA 510(k) clearance on 1995-10-31, under 510(k) number K953442.

Who is the listed applicant for RESTORE, THERMACELLS (HOT PACK I)?

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

What is the FDA product code for RESTORE, THERMACELLS (HOT PACK I)?

The FDA product code for RESTORE, THERMACELLS (HOT PACK I) is IMD.

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Related Devices (Code: IMD)

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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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