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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K022156
Device Name LATEX ULTRASONIC PROBE COVER
Applicant
Pleasure Latex Products Sdn. Bhd.
Lot 1365, 17th Miles, Jalan
Sungai Sembilang
Jeram, Selangor Darul Ehsan,  MY 45800
Applicant Contact KOI-YONG LIM
Correspondent
Pleasure Latex Products Sdn. Bhd.
Lot 1365, 17th Miles, Jalan
Sungai Sembilang
Jeram, Selangor Darul Ehsan,  MY 45800
Correspondent Contact KOI-YONG LIM
Regulation Number892.1570
Classification Product Code
ITX  
Date Received07/02/2002
Decision Date 09/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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