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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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