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510(k) K945179

BOTTLE COLLECTION SET by Medgyn Products, Inc. — Product Code HGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1995
Date Received
October 24, 1994
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

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  • K880196 — LAMINARIA (May 6, 1988)
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Other clearances for product code HGF

  • K905115 — BIOVISION ENDOCULAR PROBE (February 11, 1991)
  • K904248 — MODEL GLASE 210 HOLMIUM LASER SYSTEM (December 14, 1990)
  • K890787 — O-020 LASER INDIRECT OPHTHALMOSCOPE (March 24, 1989)