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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K851895
Device Name POLYGEL ULTRASOUND GEL
Applicant
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Applicant Contact MARTIN BUCHALTER
Correspondent
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Correspondent Contact MARTIN BUCHALTER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received04/30/1985
Decision Date 09/27/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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