510(k) K080040

Device: ORTHO ALL-FLEX DIAPHRAGM
Applicant: JOHNSON & JOHNSON PRODUTOS PROFISSIONAIS LTDA.
510(k) number: K080040
Product code: HDW
Decision: Substantially Equivalent (SESE)
Decision date: 2008-08-25
Date received: 2008-01-07
Regulation: 884.5350
Classification name: Diaphragm, Contraceptive (and Accessories)
Medical specialty: Obstetrics/Gynecology
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: WILLIAM GREENROSE
Address: 220 River Rd. Claremont NH US 03743 03743

FDA Registration Numbers#

1216677
3011014178
3013942365

Source Documents#

Other 510(k) Records For Product Code HDW #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K140305	CAYA CONTOURED DIAPHRAGM	Kessel Medintim GmbH	2014-08-26
K063223	MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS	CooperSurgical, Inc.	2008-01-23
K800162	ONCE TM	G.D. Searle and Co.	1980-02-11

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases