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510(k) K013446

GLUSITE, MODEL GLU002 by Glustitch, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2001
Date Received
October 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Glustitch, Inc.

  • K150032 — GluStitch Twist Tissue Adhesive (January 14, 2016)
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  • 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)

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