HDW — Diaphragm, Contraceptive (And Accessories) Class II

FDA Device Classification

Classification Details

Product Code
HDW
Device Class
Class II
Regulation Number
884.5350
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K140305kessel medintimCAYA CONTOURED DIAPHRAGMAugust 26, 2014
K080040johnson and johnson produtos profissionais ltdaORTHO ALL-FLEX DIAPHRAGMAugust 25, 2008
K063223coopersurgicalMILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL January 23, 2008
K800162g.d. searle andONCE TMFebruary 11, 1980