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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, Transcutaneous, For Pain Relief
510(k) Number K894127
Device Name LUMISCOPE MODEL 1000/APCC MODEL 1000
Applicant
Lumiscope Co., Inc.
400 Raritan Center Pkwy.
Edison,  NJ  08837
Applicant Contact STEVEN RAY
Correspondent
Lumiscope Co., Inc.
400 Raritan Center Pkwy.
Edison,  NJ  08837
Correspondent Contact STEVEN RAY
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/12/1989
Decision Date 09/06/1989
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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