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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, gel, electrosurgical
510(k) Number K871565
Device Name ULTRASOUND TRANSDUCER GEL, STERILE
Applicant
AMEDIC USA
3702 EAST ROESER RD, STE
27,P.O.B.62404
PHOENIX,  AZ  85040 -3969
Applicant Contact JACK A MOORE
Correspondent
AMEDIC USA
3702 EAST ROESER RD, STE
27,P.O.B.62404
PHOENIX,  AZ  85040 -3969
Correspondent Contact JACK A MOORE
Regulation Number878.4400
Classification Product Code
JOT  
Date Received04/22/1987
Decision Date 07/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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