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FDA 510(k), K953442, RESTORE, THERMACELLS (HOT PACK I)
FDA 510(k), K953442, RESTORE, THERMACELLS (HOT PACK I)
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510(K) Number: K953442
Device Name: RESTORE, THERMACELLS (HOT PACK I)
Manufacturer: NEAL DUNNING ASSOC., INC.
Device Classification Name: pack, hot or cold, disposable
Regulation Number: 890.5710
Classification Product Code: IMD
Date Received: 07/17/1995
Decision Date: 10/31/1995
Regulation Medical Specialty: Physical Medicine
Device Name: RESTORE, THERMACELLS (HOT PACK I)
Manufacturer: NEAL DUNNING ASSOC., INC.
Device Classification Name: pack, hot or cold, disposable
Regulation Number: 890.5710
Classification Product Code: IMD
Date Received: 07/17/1995
Decision Date: 10/31/1995
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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