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510(k) K030574

GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER by Glustitch, Inc. — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2003
Date Received
February 24, 2003
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)
  • K083752 — GLUSEAL 90, MODEL GLU9010 (February 23, 2009)
  • K071484 — PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 (October 10, 2007)
  • K013446 — GLUSITE, MODEL GLU002 (December 20, 2001)

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