CAYA CONTOURED DIAPHRAGM— 510(k) K140305

Substantially Equivalent

Kessel Medintim GmbH

FDA 510(k) clearance K140305 for CAYA CONTOURED DIAPHRAGM, Substantially Equivalent on 2014-08-26. Applicant: Kessel Medintim GmbH. Device class: 2.

Clearance details

Applicant: Kessel Medintim GmbH
Product code: Code HDW
Device class: Class 2
Regulation: 21 CFR 884.5350
Advisory panel: Obstetrics/Gynecology
Date received: 2014-02-07
Decision date: 2014-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frankfurt, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code HDW

K080040 — ORTHO ALL-FLEX DIAPHRAGM2008-08-25
K063223 — MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS2008-01-23
K800162 — ONCE TM1980-02-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.