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510(k) K140305

CAYA CONTOURED DIAPHRAGM by Kessel Medintim GmbH — Product Code HDW

K140305 is an FDA 510(k) premarket notification submitted by Kessel Medintim GmbH for the device "CAYA CONTOURED DIAPHRAGM". The FDA issued a decision of Substantially Equivalent on August 26, 2014. The device falls under product code HDW (Diaphragm, Contraceptive (And Accessories)), a Class II device regulated under 21 CFR 884.5350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2014
Date Received
February 7, 2014
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

Other clearances for product code HDW

  • K080040 — ORTHO ALL-FLEX DIAPHRAGM (August 25, 2008)
  • K063223 — MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL (January 23, 2008)
  • K800162 — ONCE TM (February 11, 1980)

FDA data resources