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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Irrigation Solution
510(k) Number K880252
Device Name THERMAL-PAK MODEL SW 1000
Applicant
Micro Tek Engineering
8724 Normandy Ln.
Centerville,  OH  45458
Applicant Contact DAVID STARKEY
Correspondent
Micro Tek Engineering
8724 Normandy Ln.
Centerville,  OH  45458
Correspondent Contact DAVID STARKEY
Regulation Number890.5950
Classification Product Code
LHC  
Date Received01/20/1988
Decision Date 02/10/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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