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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 K941995
Device Name NCE REPLACEMENT BATTERIES
Applicant
National Custom Ent., Inc.
400 Gateway Blvd.
Burnsville,  MN  55337
Applicant Contact MICHAEL A BENYO
Correspondent
National Custom Ent., Inc.
400 Gateway Blvd.
Burnsville,  MN  55337
Correspondent Contact MICHAEL A BENYO
Regulation Number870.5300
Classification Product Code
LDD  
Subsequent Product Code
DRK  
Date Received04/25/1994
Decision Date 07/26/1994
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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