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510(k) K950880

AOI UNIVERSAL ULTRASONIC HANDPIECE by American Optical Corp. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1995
Date Received
February 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

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