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510(k) K863591

ENDOPHOTOCOAGULATION PROBE by Mira, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1986
Date Received
September 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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  • K863246 — MIRALITE (October 31, 1986)
  • K855105 — SIMMONS SHELL (March 31, 1986)

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