PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000

Mask, Surgical

PROTECTAIDE, INC.

The following data is part of a premarket notification filed by Protectaide, Inc. with the FDA for Protectaide Personal Protection Pack No. 18000.

Pre-market Notification Details

Device IDK942474
510k NumberK942474
Device Name:PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000
ClassificationMask, Surgical
Applicant PROTECTAIDE, INC. 605 WHITE HILLS DR. Rockwall,  TX  75087
ContactJan Davis
CorrespondentJan Davis
PROTECTAIDE, INC. 605 WHITE HILLS DR. Rockwall,  TX  75087
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-25
Decision Date1994-10-18

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