ALLPORT MASTOID RETRACTORS

Retractor, Ent

EDWARD WECK, INC.

The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Allport Mastoid Retractors.

Pre-market Notification Details

Device IDK772392
510k NumberK772392
Device Name:ALLPORT MASTOID RETRACTORS
ClassificationRetractor, Ent
Applicant EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKAL  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-12-27
Decision Date1978-01-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.