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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ocular peg
510(k) Number K974203
Device Name PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM
Applicant
INTEGRATED ORBITAL IMPLANTS, INC.
4329 GRAYDON RD.
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
INTEGRATED ORBITAL IMPLANTS, INC.
4329 GRAYDON RD.
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number886.3320
Classification Product Code
MQU  
Date Received11/10/1997
Decision Date 02/04/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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