PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150— 510(k) K050355

Substantially Equivalent

Tissue Science Laboratories, Plc

FDA 510(k) clearance K050355 for PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150, Substantially Equivalent on 2005-03-09. Applicant: Tissue Science Laboratories, Plc. Device class: 3.

Clearance details

Applicant
Tissue Science Laboratories, Plc
Product code
Code PAI
Device class
Class 3
Regulation
21 CFR 884.5980
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Covington, GA, US
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