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510(k) K000731

MODIFICATION TO RTA RETINAL THICKNESS ANALYZER by Talia Technology , Ltd. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2000
Date Received
March 6, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Talia Technology , Ltd.

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  • K031312 — RTA MODEL D RETINAL THICKNESS ANALYZER (May 6, 2003)
  • K964137 — RTA RETINAL THICKNESS ANALYZER (February 3, 1997)
  • K930518 — TALIA LASER SLIT (January 25, 1994)

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