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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mallet, Surgical, General & Plastic Surgery
510(k) Number K844017
Device Name MICROTENS 7757 T.E.N.S. STIMULATOR
Applicant
Rabar, Inc.
111 Oneta Rd.
Rochester,  NY  14617
Applicant Contact BERNARD WEINSTEIN
Correspondent
Rabar, Inc.
111 Oneta Rd.
Rochester,  NY  14617
Correspondent Contact BERNARD WEINSTEIN
Regulation Number878.4800
Classification Product Code
GFJ  
Date Received10/15/1984
Decision Date 11/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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