FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
VIVOSORB SHEET, MODEL FS01
K Number: K042811
·
Decision Nov 8, 2004
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
9
Review Days
27
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Basic Information
- Device Name
- VIVOSORB SHEET, MODEL FS01
- K Number
- K042811
- 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
- Polyganics B.V.,
- Date Received
- October 12, 2004
- Decision Date
- November 8, 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 Polyganics B.V.,
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|---|---|---|---|
| K141816 | HEMOPORE | Oct 23, 2014 | Substantially Equivalent |
| K141423 | NASOPORE-FD | Aug 7, 2014 | Substantially Equivalent |
| K112267 | NEUROLAC(R) NERVE GUIDE | Oct 20, 2011 | Substantially Equivalent |
| K070715 | NASOPORE EAR | May 7, 2007 | Substantially Equivalent |
| K062540 | NASOPORE EAR, MODELS ND04, ND05 | Oct 18, 2006 | Substantially Equivalent |
| K052099 | NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ | Nov 21, 2005 | Substantially Equivalent |
| K050573 | NEUROLAC NERVE GUIDE | May 4, 2005 | Substantially Equivalent |
| K032115 | NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 | Oct 10, 2003 | Substantially Equivalent |