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510(k) K905115

BIOVISION ENDOCULAR PROBE by Douglas James Donaldson Compliance Services — Product Code HGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1991
Date Received
November 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Abortion Unit, Vacuum
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type

Other clearances by Douglas James Donaldson Compliance Services

  • K912987 — CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE (October 28, 1991)
  • K912284 — BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF (August 19, 1991)
  • K905453 — CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND (March 5, 1991)
  • K904366 — CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR (October 19, 1990)

Other clearances for product code HGF

  • K945179 — BOTTLE COLLECTION SET (January 26, 1995)
  • K904248 — MODEL GLASE 210 HOLMIUM LASER SYSTEM (December 14, 1990)
  • K890787 — O-020 LASER INDIRECT OPHTHALMOSCOPE (March 24, 1989)