PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150

K Number: K050355 · Decision Mar 9, 2005

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Device Name: PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150
K Number: K050355
Device Class: FDA class 3
Clearance Type: Special
Regulation Number: 884.5980
Medical Specialty: Obstetrics/Gynecology
Decision: Substantially Equivalent
Statement or Summary: Summary
Applicant: Tissue Science Laboratories, Plc
Date Received: February 14, 2005
Decision Date: March 9, 2005
Product Code: PAI
Advisory Committee: Obstetrics/Gynecology
Review Advisory Committee: OB
Third Party: N

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
PAI	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed	FDA class 3	Obstetrics/Gynecology

Other 510(k) clearances with the same product code (PAI), ordered by most recent decision date.

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K Number	Device Name	Decision Date	Decision
K053562	ZIMMER COLLAGEN REPAIR PATCH	Jun 23, 2006	Substantially Equivalent
K043366	PERMACOL SURGICAL IMPLANT	Dec 17, 2004	Substantially Equivalent
K021056	PERMACOL	Oct 31, 2002	Substantially Equivalent
K013625	PERMACOL	Jan 17, 2002	Substantially Equivalent
K992556	PERMACOL	Feb 17, 2000	Substantially Equivalent