GLASSMAN STONE EXTRACTION SET

Dislodger, Stone, Biliary

WILSON-COOK MEDICAL, INC.

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Glassman Stone Extraction Set.

Pre-market Notification Details

Device IDK904472
510k NumberK904472
Device Name:GLASSMAN STONE EXTRACTION SET
ClassificationDislodger, Stone, Biliary
Applicant WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem,  NC  27105
ContactRichard F Marshall
CorrespondentRichard F Marshall
WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem,  NC  27105
Product CodeLQR  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-10-01
Decision Date1990-12-28

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