FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERMACOL SURGICAL IMPLANT
K Number: K043366
·
Decision Dec 17, 2004
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
6
Review Days
9
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Basic Information
- Device Name
- PERMACOL SURGICAL IMPLANT
- K Number
- K043366
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tissue Science Laboratories, Plc
- Date Received
- December 8, 2004
- Decision Date
- December 17, 2004
- Product Code
- FTL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Tissue Science Laboratories, Plc
| K Number | Device Name | ||
|---|---|---|---|
| K053562 | ZIMMER COLLAGEN REPAIR PATCH | Jun 23, 2006 | Substantially Equivalent |
| K050355 | PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 | Mar 9, 2005 | Substantially Equivalent |
| K021056 | PERMACOL | Oct 31, 2002 | Substantially Equivalent |
| K013625 | PERMACOL | Jan 17, 2002 | Substantially Equivalent |
| K992556 | PERMACOL | Feb 17, 2000 | Substantially Equivalent |