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510(k) K955463

Device
GRIP-A-BOOTS
Applicant
SIL-MED CORP.
510(k) number
K955463
Product code
LXZ  
Decision
Substantially Equivalent (SESE)
Decision date
1996-01-23
Date received
1995-11-29
Regulation
878.4800
Classification name
Guard, Instrument
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KAREN K SYLVIA
Address
700 Warner Blvd. Taunton MA US 02780 02780

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LXZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K834127INSTRUMENT TIP PROTECTION COVERSDevon Industries, Inc.1984-02-17

Legacy Summary#

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FDA Review#

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