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510(k) K915412

HYSTEROSCOPIC MYOMA SCREW by Cook Urological, Inc. — Product Code HHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1992
Date Received
December 2, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fibroid, Gynecological
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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Other clearances for product code HHO

  • K915388 — LAPAROCOPIC MYOMA SCREW (May 18, 1992)