510(k) K874279

Device: Ahh Natural Breast Form
Applicant: PACIFIC PROSTHETICS, INC.
510(k) number: K874279
Product code: GBI
Decision: Substantially Equivalent (SESE)
Decision date: 1987-10-29
Date received: 1987-10-20
Regulation: 878.3800
Classification name: Material, External Aesthetic Restoration, Used With Adhesive
Medical specialty: General, Plastic Surgery
Review panel: General, Plastic Surgery
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

510(k) summary PDF not indicated by FDA

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K880329	FACTOR II PROSTHETIC SILICONE ELASTOMER	Factor, Ii, Inc.	1988-06-01
K872714	S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY	Roseburg SA	1987-07-21
K864786	PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT	Coloplast Corp.	1987-01-08
K864785	AMOENA BREAST FORMS	Coloplast Corp.	1987-01-08
K853822	AMOENA BREAST FORMS	Coloplast Corp.	1985-09-30
K851668	PROSTHESIS OR SURGICAL PADS	Virginia Hall, Inc.	1985-06-04
K842765	SILIMED BREAST FORM	Sil-Med Corp.	1984-08-17
K841559	CONFORMA	Beiersdorf, Inc.	1984-07-17
K841171	TRILICON BREASE PROSTHESIS DIFFERENT	Baurs Krey Assoc., Inc.	1984-04-25
K832151	PDM SILOXANE PROSTHETIC ORBIT	Delaware Prosthetics, Inc.	1983-12-19
K832153	PDM SILOXANE PROSTHETIC NOSE	Delaware Prosthetics, Inc.	1983-12-09
K832152	PDM SILOXANE PROSTHETIC EAR	Delaware Prosthetics, Inc.	1983-12-09
K831831	TRULIFE SILICONE BREAST FORM	Medeering, Ltd.	1983-06-30
K813416	EXTERNAL BREAST PROSTHESIS	Surgical Appliance Industries, Inc.	1982-01-18
K792372	IPOS BREAST PROSTHESIS	Ipos KG	1979-12-19