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510(k) K111453

STEAM DOT BLU PROCESS INDICATOR by Propper Mfg. Co., Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2012
Date Received
May 25, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

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  • K991276 — PASS/FAIL CHALLENGE PACK (July 12, 1999)
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  • K972747 — BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) (January 9, 1998)
  • K961156 — ONCE-A-DAY BOWIE AND DICK TEST PACK. (April 1, 1997)
  • K921798 — PROPPER SUPER SERACULT(R) (October 5, 1992)
  • K915804 — PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM. (March 20, 1992)

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