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510(k) K200493

Device
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered With Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
Applicant
Stryker Corporation
510(k) number
K200493
Product code
FXY  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-21
Date received
2020-02-28
Regulation
878.4040
Classification name
Hood, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Corinne Larke-Grass
Address
4100 E. Milham Ave. Kalamazoo MI US 49001 49001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FXY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222214ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)Thi Total Healthcare Innovation GmbH2023-10-17
K140588FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSStryker Corporation2014-06-26
K904969HOOD, OPERATING, SURGICALChicago Assoc. For Retarded Citizens1990-12-12
K904276DISPOSABLE BEARD COVERAnago, Inc.1990-11-21
K903533STERI-SHIELDBiomedical Devices, Inc.1990-10-19
K902677STERI-SHIELDBiomedical Devices, Inc.1990-08-17
K880431CARETEX SURGEON'S HOODSJames River Corp.1988-02-24
K770261HOOD, CLARION SURGEONSSherwood Medical Industries1977-03-01
K770257HOOD & BEARD COVER, CLARION SURGEON'SSherwood Medical Industries1977-02-25
K761070P.S.M. SURGICAL HOODThe Owenby Co.1976-12-30
K760855BARRIER SURGICAL HOODSurgikos, Inc.1976-11-03
K760865BARRIER FASHION BONNETSurgikos, Inc.1976-11-03

Legacy Summary#

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FDA Review#

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