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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 K905545
Device Name ULTRASOUND TRANSMISSION GEL
Applicant
ARBO MEDICAL, INC.
300 LONG BEACH BLVD.
STRATFORD,  CT  06497
Applicant Contact WAYNE D SHOCKLOSS
Correspondent
ARBO MEDICAL, INC.
300 LONG BEACH BLVD.
STRATFORD,  CT  06497
Correspondent Contact WAYNE D SHOCKLOSS
Regulation Number878.4400
Classification Product Code
JOT  
Date Received12/11/1990
Decision Date 03/29/1991
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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