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510(k) K071484

PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 by Glustitch, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2007
Date Received
May 30, 2007
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.

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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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