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510(k) K952241

Device
PROTOUCH OVERGLOVE
Applicant
COTTRELL, LTD.
510(k) number
K952241
Product code
MMP  
Decision
Substantially Equivalent (SESE)
Decision date
1995-08-07
Date received
1995-05-12
Regulation
878.4370
Classification name
Cover, Barrier, Protective
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
FRANK S CASCIANI
Address
49 Plain St. North Attleboro MA US 02760 02760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MMP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K091178MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREENMtp Medical Technical Promotion GmbH2009-07-31
K043234LIGHT DRAPEWrapped IN Comfort2005-05-25
K041501GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERSGuangzhou Fortunique , Ltd.2004-11-30
K040794INCUBATOR CAPEWrapped IN Comfort2004-06-10
K032065MEDLINE BAND BAGS AND EQUIPMENT COVERSMedline Industries, Inc.2003-09-22
K023540SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09Valumed2003-02-04
K014239MEDSURG EQUIPMENT COVERSInternational Medsurg Connection2002-02-19
K970885ULTRASOUND SYSTEMS DRAPEProtek Medical Products, Inc.1997-09-22
K962288COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVERPinnacle Products, Inc.1997-01-30
K961699EQUIPMENT COVERSUnited States Surgical, A Division of Tyco Healthc1996-08-23
K931417STERILE EQUIPMENT COVERSCustom Medical Products, Ltd.1995-07-06
K944198SURGICAL MICROSCOPE DRAPEHydro-Med Products, Inc.1994-11-27
K930552STERILE BARRIER SLEEVE AND COVERPatient Safety Products, Inc.1994-07-05
K820692BANDBAG, WRAP, STERILEContour Fabricators, Inc.1982-05-03

Legacy Summary#

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FDA Review#

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