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510(k) K942828

Device
MAKAR FULL AND HALF FACE SHIELD
Applicant
INSTRUMENT MAKAR, INC.
510(k) number
K942828
Product code
LYU  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-23
Date received
1994-06-14
Regulation
878.4040
Classification name
Accessory, Surgical Apparel
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEANNIE M CLEARY
Address
2950 E. Mt. Hope Rd. Okemos MI US 48864 48864

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LYU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.2001-06-22
K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.1997-08-27
K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.1997-07-10
K964364DISPOSABLE APRONInstrument Makar, Inc.1997-02-25
K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.1996-08-09
K961454AMMI MAGNI-GUARDAmerican Medical Mfg., Inc.1996-07-25
K945302SLOAN STA-DRI PANT PROTECTORSloan Corp.1996-03-19
K954314ULTRAFIT LINERSStahmer Weston Scientific1995-12-28
K953089I-SPOUSEProducts For Medicine1995-10-16
K952303SPLASH ASSISTInnovative Outsourcing Solutions1995-08-24
K942200ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPSThantex Specialties, Inc.1995-08-07
K944118SLOAN STA-DRI SURGICAL JUMPSUITSloan Corp.1995-07-31
K944276SLOAN STA-DRI BOOTLEG LEGGINGSloan Corp.1995-07-31
K946003INTEC FULL FACE SHIELDIntec Industries, Inc.1995-06-28
K951420INCASE EXTENSIBLE BAG--NON-STERILEAlpha Surgical, Inc.1995-06-08

Legacy Summary#

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FDA Review#

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