PROTEKT GLOVES

Dress, Surgical

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Protekt Gloves.

Pre-market Notification Details

Device IDK910920
510k NumberK910920
Device Name:PROTEKT GLOVES
ClassificationDress, Surgical
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactThomas L Craig
CorrespondentThomas L Craig
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeFYE  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-05
Decision Date1991-05-15

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