ProTEC-USA EZDoff Gown

Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection

Cadillac Products, Inc.

The following data is part of a premarket notification filed by Cadillac Products, Inc. with the FDA for Protec-usa Ezdoff Gown.

Pre-market Notification Details

Device IDK210405
510k NumberK210405
Device Name:ProTEC-USA EZDoff Gown
ClassificationGown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection
Applicant Cadillac Products, Inc. 5800 Crooks Road, Suite 100 Troy,  MI  48098
ContactAndrew Stone
CorrespondentDennis Gucciardo
Morgan Lewis & Bockius LLP 1111 Pennsylvania Ave Washington,  DC  20004 -2541
Product CodeQPC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-10
Decision Date2021-12-15

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