3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95

Mask, Surgical

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Model 1860 Health Care Particulate Respirator Type N95.

Pre-market Notification Details

Device IDK955382
510k NumberK955382
Device Name:3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
ClassificationMask, Surgical
Applicant 3M COMPANY BUILDINGS 251-3 AND 270 St. Paul,  MN  55144 -1000
ContactDorothea Von Busch
CorrespondentDorothea Von Busch
3M COMPANY BUILDINGS 251-3 AND 270 St. Paul,  MN  55144 -1000
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-24
Decision Date1996-05-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50707387444124 K955382 000
50707387419429 K955382 000
50051131275541 K955382 000
50051131275534 K955382 000
58887719257409 K955382 000
58887719257393 K955382 000

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