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510(k) K931167

OVAMED FALLOPIAN OSTIAL ACCESS CATHETER by Ovamed Corp. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1995
Date Received
March 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Ovamed Corp.

  • K951946 — HYSTEROSYS FLEXIBLE HYSTEROCOPE (November 20, 1995)
  • K931534 — OVAMED INTRAUTERINE ACCESS CATHETER (July 28, 1995)
  • K943593 — SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM (March 22, 1995)
  • K931122 — OVAMED HSG CATHETER (January 30, 1995)

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