Atlas FDA

PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL

FDA 510(k) clearance K974068 · decided 1997-12-22

Clearance details

K-number
K974068
Device name
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
Applicant
Tecnol Medical Products, Inc.
Decision
Substantially Equivalent
Date received
1997-10-28
Decision date
1997-12-22
Days to decision
55 days
Clearance type
Traditional
Product code
MSH
Device class
2
Regulation number
878.4040
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Fort Worth, TX, US
Third-party review
No
Expedited review
No

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3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK (K121069)3M Company2013-02-11
BARRIER N95 PARTICULATE RESPIRATOR (K102923)Molnlycke Health Care2010-11-19
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Recalls involving this device

RecordFirmDate
FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Or recall (Z-2626-2023)O&M HALYARD, INC.2023-09-21