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510(k) K943379

PHACO TIPS FOR PHACO FRAGMENTATION MACHINES by Oasis Medical, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1994
Date Received
July 13, 1994
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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  • K013613 — SOFT PLUG ABSORBABLE PLUG-SA (June 27, 2002)
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  • K001176 — DISPOSABLE MICROKERATOME BLADES-PE (September 21, 2000)
  • K980437 — SILICONE PUNCTAL PLUG (April 30, 1998)
  • K950798 — POSTERIOR CAPSULE SHIELD (May 22, 1995)

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