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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 K884032
Device Name MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
Applicant
MORGAN ASSOCIATES, INC.
21 WEST 39TH ST.
NEW YORK,  NY  10018
Applicant Contact JOSEPH FRISONE
Correspondent
MORGAN ASSOCIATES, INC.
21 WEST 39TH ST.
NEW YORK,  NY  10018
Correspondent Contact JOSEPH FRISONE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/23/1988
Decision Date 10/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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