HEMOSPENSER CARTRIDGE CAT. NO. 523500-

Applier, Surgical, Clip

EDWARD WECK, INC.

The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Hemospenser Cartridge Cat. No. 523500-.

Pre-market Notification Details

Device IDK792378
510k NumberK792378
Device Name:HEMOSPENSER CARTRIDGE CAT. NO. 523500-
ClassificationApplier, Surgical, Clip
Applicant EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGDO  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-26
Decision Date1979-12-06

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