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510(k) K083752

GLUSEAL 90, MODEL GLU9010 by Glustitch, Inc. — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2009
Date Received
December 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

Other clearances by Glustitch, Inc.

  • K150032 — GluStitch Twist Tissue Adhesive (January 14, 2016)
  • K071484 — PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 (October 10, 2007)
  • K030574 — GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER (August 21, 2003)
  • K013446 — GLUSITE, MODEL GLU002 (December 20, 2001)

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