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510(k) K063223

MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS by CooperSurgical, Inc. — Product Code HDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2008
Date Received
October 24, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diaphragm, Contraceptive (And Accessories)
Device Class
Class II
Regulation Number
884.5350
Review Panel
OB
Submission Type

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Other clearances for product code HDW

  • K140305 — CAYA CONTOURED DIAPHRAGM (August 26, 2014)
  • K080040 — ORTHO ALL-FLEX DIAPHRAGM (August 25, 2008)
  • K800162 — ONCE TM (February 11, 1980)