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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, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
510(k) Number K900759
Device Name POLY-OP (TM)
Applicant
Nu-Gyn-Tek, Inc.
P.O. Box 75
Oakfield,  NY  14125
Applicant Contact JAEGER, M.D.
Correspondent
Nu-Gyn-Tek, Inc.
P.O. Box 75
Oakfield,  NY  14125
Correspondent Contact JAEGER, M.D.
Regulation Number882.5890
Classification Product Code
OCF  
Subsequent Product Code
FCF  
Date Received02/16/1990
Decision Date 05/24/1990
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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