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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 K871666
Device Name MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR
Applicant
ORIENTAL MEDICAL SUPPLIES, INC.
1950 WASHINGTON ST.
BRAINTREE,  MA  02184
Applicant Contact THOMAS RIIHIMAKI
Correspondent
ORIENTAL MEDICAL SUPPLIES, INC.
1950 WASHINGTON ST.
BRAINTREE,  MA  02184
Correspondent Contact THOMAS RIIHIMAKI
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/28/1987
Decision Date 06/25/1987
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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