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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K905568
Device Name TOPICAL COOLING PAD, MODEL 7000
Applicant
Daily Medical Products, Inc.
3665 Kearny Villa Rd.
Suite 301
San Diego,  CA  92123
Applicant Contact ALAN SEACORD
Correspondent
Daily Medical Products, Inc.
3665 Kearny Villa Rd.
Suite 301
San Diego,  CA  92123
Correspondent Contact ALAN SEACORD
Regulation Number870.4240
Classification Product Code
DTR  
Date Received12/12/1990
Decision Date 01/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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