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510(k) K020527

HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 by American Optisurgical, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2002
Date Received
February 19, 2002
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

Other clearances by American Optisurgical, Inc.

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  • K953538 — RM001 REUSABLE (December 26, 1995)
  • K952331 — AOI LC-40 PHACOEMULSIFIER (August 16, 1995)

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