KAPPLER PRO/VENT BOOT

Cover, Shoe, Operating-room

KAPPLER, INC.

The following data is part of a premarket notification filed by Kappler, Inc. with the FDA for Kappler Pro/vent Boot.

Pre-market Notification Details

Device IDK932738
510k NumberK932738
Device Name:KAPPLER PRO/VENT BOOT
ClassificationCover, Shoe, Operating-room
Applicant KAPPLER, INC. P.O. BOX 218 5000 GRIMES DRIVE Guntersville,  AL  35976
ContactPhillip C Mann
CorrespondentPhillip C Mann
KAPPLER, INC. P.O. BOX 218 5000 GRIMES DRIVE Guntersville,  AL  35976
Product CodeFXP  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-07
Decision Date1994-03-29

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