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510(k) K060151

ORBITAL TISSUE EXPANDER (OTE) by Innovia, LLC — Product Code NFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2006
Date Received
January 20, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Expander, Tissue, Orbital
Device Class
Class II
Regulation Number
886.3320
Review Panel
OP
Submission Type

Other clearances by Innovia, LLC

  • K093783 — INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT (August 23, 2010)
  • K090677 — INNOPORT LAPAROSCOPIC ACCESS DEVICE (May 7, 2009)

Other clearances for product code NFM

  • K010852 — OSMED TISSUE EXPANDER (August 13, 2001)