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510(k) K042099

TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) by Retinapharma Technologies, Inc. — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2004
Date Received
August 4, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

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