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510(k) K150032

GluStitch Twist Tissue Adhesive by Glustitch, Inc. — Product Code MPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2016
Date Received
January 8, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Adhesive For The Topical Approximation Of Skin
Device Class
Class II
Regulation Number
878.4010
Review Panel
SU
Submission Type

Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).

Other clearances by Glustitch, Inc.

  • K083752 — GLUSEAL 90, MODEL GLU9010 (February 23, 2009)
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  • K030574 — GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER (August 21, 2003)
  • K013446 — GLUSITE, MODEL GLU002 (December 20, 2001)

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