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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated external defibrillators (non-wearable)
510(k) Number K943698
Device Name STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES
Applicant
ZOLL MEDICAL CORP.
32 SECOND AVE.
BURLINGTON,  MA  01803 -4420
Applicant Contact BLAKE A CERULLO
Correspondent
ZOLL MEDICAL CORP.
32 SECOND AVE.
BURLINGTON,  MA  01803 -4420
Correspondent Contact BLAKE A CERULLO
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received07/29/1994
Decision Date 12/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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