FELDMAN MINI-SAW, #300000

Saw, Surgical, Ent (electric Or Pneumatic)

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Feldman Mini-saw, #300000.

Pre-market Notification Details

Device IDK800669
510k NumberK800669
Device Name:FELDMAN MINI-SAW, #300000
ClassificationSaw, Surgical, Ent (electric Or Pneumatic)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEWQ  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-26
Decision Date1980-04-21

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