AUTOMATIC HEMOCLIP APPLIER, 527700

Staple, Implantable

EDWARD WECK, INC.

The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Automatic Hemoclip Applier, 527700.

Pre-market Notification Details

Device IDK810324
510k NumberK810324
Device Name:AUTOMATIC HEMOCLIP APPLIER, 527700
ClassificationStaple, Implantable
Applicant EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-02-06
Decision Date1981-03-20

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