ULTRASOUND TRANSDUCER DRAPE

Drape, Surgical

PROTEK MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Protek Medical Products, Inc. with the FDA for Ultrasound Transducer Drape.

Pre-market Notification Details

Device IDK970889
510k NumberK970889
Device Name:ULTRASOUND TRANSDUCER DRAPE
ClassificationDrape, Surgical
Applicant PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City,  IA  52245
ContactRick L Pruter
CorrespondentRick L Pruter
PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City,  IA  52245
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-11
Decision Date1997-10-20
Summary:summary

NIH GUDID Devices

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