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510(k) K082767

KOWA NONMYD ALPHA-DIII by Kowa Co. , Ltd. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2008
Date Received
September 22, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

Other clearances by Kowa Co. , Ltd.

  • K133755 — KOWA SL-17 (March 11, 2014)
  • K112330 — KOWA VX-20 (February 16, 2012)
  • K101628 — KOWA NONMYD WX (January 26, 2011)
  • K091039 — KOWA, FM-600, MODEL LSS50 (August 7, 2009)
  • K091098 — KOWAGENESIS-DF (August 7, 2009)
  • K091683 — KOWA VX-10 A (July 2, 2009)
  • K083387 — MODIFICATION TO KOWA NONMYD ALPHA-DIII (January 16, 2009)
  • K080681 — KOWA GENESIS-D (April 4, 2008)
  • K063640 — KOWA SL-15 (December 18, 2006)
  • K062021 — KOWA VX-10I (November 1, 2006)

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