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510(k) K931354

P4000 PHACOEMULSIFIER by American Optical Corp. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1994
Date Received
March 17, 1993
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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  • K811535 — MODEL FUS-1, FLEXIBLE URETEROSCOPE (June 23, 1981)

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