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510(k) K910941

Device
LIFELINER SURGICAL GLOVE
Applicant
DEPUY-RAYNHAM
510(k) number
K910941
Product code
FYE  
Decision
Substantially Equivalent (SESE)
Decision date
1991-05-09
Date received
1991-03-06
Regulation
878.4040
Classification name
Dress, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID A KOTKOVETZ
Address
P.O. Box 988 Warsaw IN US 46580 46580

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FYE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932731BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWNJohnson & Johnson Medical, Inc.1994-04-11
K912790SURGICAL GOWNUnicor Federal Dept. of Justice1991-09-19
K910920PROTEKT GLOVESIntermedics Orthopedics1991-05-15
K895667STERILE SURGICAL GOWNClinitech, Inc.1989-10-13
K895235VARIOUS DISPOSABLE SURGICAL GARMENTSProtect Corp. of Indiana, Inc.1989-09-19
K894760CLOTHINGUARDBarrier Concepts, Inc.1989-08-18

Legacy Summary#

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FDA Review#

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