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510(k) K951590

ASSURE, SELF-SEALING STERILIZATION POUCH by Sultan Chemists, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1995
Date Received
April 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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  • K043054 — GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL (February 18, 2005)
  • K030414 — GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL (April 9, 2003)
  • K020612 — SULTAN SPOROX TEST VIAL, MODEL 75195 (May 7, 2002)
  • K002843 — SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 (November 15, 2000)
  • K991509 — PRO-PORTION CLEANER/DISINFECTANT (July 14, 1999)
  • K971138 — DINABASE (TM) (July 21, 1997)
  • K933729 — ASSURE SELF SEALING STERILIZATION POUCH (June 21, 1994)
  • K896826 — SULTAN PERIO-SELECT IRRIGATION SYSTEM (March 2, 1990)

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