PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE

Drape, Surgical

MEDICAL CREATIVE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Creative Technologies, Inc. with the FDA for Protector Retractor & Protector Retractor With Drape.

Pre-market Notification Details

Device IDK954824
510k NumberK954824
Device Name:PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE
ClassificationDrape, Surgical
Applicant MEDICAL CREATIVE TECHNOLOGIES, INC. 2950-N ADVANCE LN. Colmar,  PA  18915 -9727
ContactPerk Crook
CorrespondentPerk Crook
MEDICAL CREATIVE TECHNOLOGIES, INC. 2950-N ADVANCE LN. Colmar,  PA  18915 -9727
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-20
Decision Date1996-04-23
Summary:summary

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