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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 K940954
FOIA Releasable 510(k) K940954
Device Name SYNAPTIC 3000
Applicant
The Synaptic Corp.
3177 S. Parker Rd.
Aurora,  CO  80014
Applicant Contact MARK K SHANER
Correspondent
The Synaptic Corp.
3177 S. Parker Rd.
Aurora,  CO  80014
Correspondent Contact MARK K SHANER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/01/1994
Decision Date 06/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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