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510(k) K782141

LEVIGATOR, KEELER PHOKO by Keeler Optical Products , Ltd. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1979
Date Received
December 27, 1978
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

Other clearances by Keeler Optical Products , Ltd.

  • K810403 — KEELER/KONAN SPECULAR MICROSCOPE (May 13, 1981)
  • K801418 — KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT (July 21, 1980)
  • K792255 — NEVYAS AUTOPRESS EYE COMPRESSOR (December 11, 1979)
  • K781892 — LOCATOR, FOREIGN BODY (December 4, 1978)

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