PDS ULTRACLEAN

Cleaner, Ultrasonic, Medical Instrument

MEDICAL POLYMERS, INC.

The following data is part of a premarket notification filed by Medical Polymers, Inc. with the FDA for Pds Ultraclean.

Pre-market Notification Details

Device IDK934666
510k NumberK934666
Device Name:PDS ULTRACLEAN
ClassificationCleaner, Ultrasonic, Medical Instrument
Applicant MEDICAL POLYMERS, INC. 8920 BUSINESS PARK DR. SUITE 290 Austin,  TX  78759
ContactThomas Vanne
CorrespondentThomas Vanne
MEDICAL POLYMERS, INC. 8920 BUSINESS PARK DR. SUITE 290 Austin,  TX  78759
Product CodeFLG  
CFR Regulation Number880.6150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-28
Decision Date1994-04-15

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