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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K963781
Device Name ZOLL AUTOCLAVABLE INTERNAL HANDLES
Applicant
Zoll Medical Corp
32 Second Ave.
Burlington,  MA  01803
Applicant Contact MAURA MCGUIRE
Correspondent
Zoll Medical Corp
32 Second Ave.
Burlington,  MA  01803
Correspondent Contact MAURA MCGUIRE
Regulation Number870.5300
Classification Product Code
LDD  
Date Received09/20/1996
Decision Date 05/20/1997
Decision SE SUBJECT TO TRACKING REG (ST)
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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