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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Battery-Powered
510(k) Number K860126
Device Name STIMUPLEX, NERVE STIMULATOR
Applicant
Burron Medical Products, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact TRACEY YAKABOW
Correspondent
Burron Medical Products, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact TRACEY YAKABOW
Regulation Number868.2775
Classification Product Code
BXN  
Date Received01/14/1986
Decision Date 02/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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