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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 K931787
Device Name ZOLL PD 5300
Applicant
ZOLL MEDICAL CORP.
500 WEST CUMMINGS PARK
WOBURN,  MA  01801
Applicant Contact BLAKE A CERULLO
Correspondent
ZOLL MEDICAL CORP.
500 WEST CUMMINGS PARK
WOBURN,  MA  01801
Correspondent Contact BLAKE A CERULLO
Regulation Number870.5300
Classification Product Code
LDD  
Subsequent Product Codes
DRK   DRO   MKJ  
Date Received04/12/1993
Decision Date 10/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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