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510(k) K082031

APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES by Appasamy Associates — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2008
Date Received
July 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Appasamy Associates

  • K110205 — AAIO-7, AAIO WIRLESS (February 9, 2011)

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  • K170470 — Digital Eye Anterior Camera (October 6, 2017)
  • K162778 — Portable Slit Lamp Microscope (July 21, 2017)
  • K162684 — SL 220 (May 31, 2017)
  • K163564 — SLIT LAMP SL-2000 (May 19, 2017)