N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695

Respirator, Surgical

ALPHAPROTECH, INC.

The following data is part of a premarket notification filed by Alphaprotech, Inc. with the FDA for N95 Respirator Mask, Positive Facial Lock With Magic Arch, Model 695.

Pre-market Notification Details

Device IDK092824
510k NumberK092824
Device Name:N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695
ClassificationRespirator, Surgical
Applicant ALPHAPROTECH, INC. 236 NORTH 2200 WEST Salt Lake City,  UT  84116
ContactDavid Kitchen
CorrespondentDavid Kitchen
ALPHAPROTECH, INC. 236 NORTH 2200 WEST Salt Lake City,  UT  84116
Product CodeMSH  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-14
Decision Date2009-10-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20817583020141 K092824 000
20817583020134 K092824 000
20817583020127 K092824 000
10080196721719 K092824 000
10889950133696 K092824 000

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