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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Ultrasonic, Medical Instrument
510(k) Number K934666
Device Name PDS ULTRACLEAN
Applicant
Medical Polymers, Inc.
8920 Business Park Dr.
Suite 290
Austin,  TX  78759
Applicant Contact THOMAS VANNE
Correspondent
Medical Polymers, Inc.
8920 Business Park Dr.
Suite 290
Austin,  TX  78759
Correspondent Contact THOMAS VANNE
Regulation Number880.6150
Classification Product Code
FLG  
Date Received09/28/1993
Decision Date 04/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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