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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 K993229
Device Name ANALGESIC PULSER, MODEL AP-439
Applicant
Johari Electro-Tech Co.
Vandana, 28 Nehru Park,
Jodhpur-342003,  IN 342003
Applicant Contact NISHA JOHARI
Correspondent
Johari Electro-Tech Co.
Vandana, 28 Nehru Park,
Jodhpur-342003,  IN 342003
Correspondent Contact NISHA JOHARI
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   LIH  
Date Received09/27/1999
Decision Date 02/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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