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510(k) K042811

VIVOSORB SHEET, MODEL FS01 by Polyganics B.V., — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2004
Date Received
October 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Polyganics B.V.,

  • K141816 — HEMOPORE (October 23, 2014)
  • K141423 — NASOPORE-FD (August 7, 2014)
  • K112267 — NEUROLAC(R) NERVE GUIDE (October 20, 2011)
  • K070715 — NASOPORE EAR (May 7, 2007)
  • K062540 — NASOPORE EAR, MODELS ND04, ND05 (October 18, 2006)
  • K052099 — NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ (November 21, 2005)
  • K050573 — NEUROLAC NERVE GUIDE (May 4, 2005)
  • K032115 — NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 (October 10, 2003)

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