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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K827296
Device Name POLYSONIC ULTRASOUND LOTION
Applicant
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Correspondent
Parker Laboratories, Inc.
307 Washington St.
Orange,  NJ  07050
Regulation Number892.1570
Classification Product Code
MUI  
Date Received03/30/1982
Decision Date 04/16/1982
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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