PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150— 510(k) K050355
Substantially EquivalentTissue 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
Recent devices under product code PAI
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