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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K881343
Device Name DURADERM BUTTERFLY
Applicant
Sentry Medical Products, Inc.
2615 S. Orange Ave.
Santa Ana,  CA  92704
Applicant Contact DAVID SHERATON
Correspondent
Sentry Medical Products, Inc.
2615 S. Orange Ave.
Santa Ana,  CA  92704
Correspondent Contact DAVID SHERATON
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/30/1988
Decision Date 05/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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