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510(k) K974203

Device
PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM
Applicant
INTEGRATED ORBITAL IMPLANTS, INC.
510(k) number
K974203
Product code
MQU  
Decision
Substantially Equivalent (SESE)
Decision date
1998-02-04
Date received
1997-11-10
Regulation
886.3320
Classification name
Ocular Peg
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
FLOYD G LARSON
Address
4329 Graydon Rd. San Diego CA US 92130 92130

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K000151PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVEIntegrated Orbital Implants, Inc.2000-04-10
K980822TITANIUM PEG SYSTEMFci Ophthalmics, Inc.1998-07-09
K971583MEDPOR OCULAR SCREW AND ACCEOSSORIESPorex Technologies Corp.1997-06-30

Legacy Summary#

summary

FDA Review#

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