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510(k) K031152

PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) by Propper Mfg. Co., Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2004
Date Received
April 11, 2003
Clearance Type
Traditional
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)
  • K973585 — PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR (November 6, 1998)
  • 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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