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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Holder, Syringe
510(k) Number K073555
Device Name INSULIN PROTECTOR
Applicant
Medicool, Inc.
20460 Gramercy Pl.
Torrance,  CA  90501
Applicant Contact EUGENE CHANG
Correspondent
Medicool, Inc.
20460 Gramercy Pl.
Torrance,  CA  90501
Correspondent Contact EUGENE CHANG
Regulation Number890.5050
Classification Product Code
IQG  
Date Received12/18/2007
Decision Date 07/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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