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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conformer, Ophthalmic
510(k) Number K945110
Device Name KOLBERG OPHTHALMIC CONFORMER
Applicant
Kolberg Ocular Products, Inc.
9663 Tierra Grande St.,
Suite 201
San Diego,  CA  92126
Applicant Contact THOMAS J MULDOON
Correspondent
Kolberg Ocular Products, Inc.
9663 Tierra Grande St.,
Suite 201
San Diego,  CA  92126
Correspondent Contact THOMAS J MULDOON
Regulation Number886.3130
Classification Product Code
HQN  
Date Received10/18/1994
Decision Date 01/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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