FLOOR LINE INSTRUMENTS

Cutter, Surgical

EDWARD WECK, INC.

The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Floor Line Instruments.

Pre-market Notification Details

Device IDK791741
510k NumberK791741
Device Name:FLOOR LINE INSTRUMENTS
ClassificationCutter, Surgical
Applicant EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFZT  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-09-10
Decision Date1979-10-04

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