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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Water Circulating
510(k) Number K843146
FOIA Releasable 510(k) K843146
Device Name MICRO-TEMP PUMPS & MICRO-TEMP PADS
Applicant
Seabrook Medical Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Seabrook Medical Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5720
Classification Product Code
ILO  
Date Received08/10/1984
Decision Date 08/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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