PERFORATED SOAKING TUBE

Catheter, Continuous Irrigation

SPECIALTY MEDICAL PRODUCTS CO.

The following data is part of a premarket notification filed by Specialty Medical Products Co. with the FDA for Perforated Soaking Tube.

Pre-market Notification Details

Device IDK874596
510k NumberK874596
Device Name:PERFORATED SOAKING TUBE
ClassificationCatheter, Continuous Irrigation
Applicant SPECIALTY MEDICAL PRODUCTS CO. 3063 SOUTH DAVIS BLVD. Bountiful,  UT  84010
ContactThomas J Haslam
CorrespondentThomas J Haslam
SPECIALTY MEDICAL PRODUCTS CO. 3063 SOUTH DAVIS BLVD. Bountiful,  UT  84010
Product CodeGBQ  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-09
Decision Date1987-12-02

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