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510(k) K945110

KOLBERG OPHTHALMIC CONFORMER by Kolberg Ocular Products, Inc. — Product Code HQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1995
Date Received
October 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conformer, Ophthalmic
Device Class
Class II
Regulation Number
886.3130
Review Panel
OP
Submission Type

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