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510(k) K972747

BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) by Propper Mfg. Co., Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1998
Date Received
July 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Propper Mfg. Co., Inc.

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  • K031152 — PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) (August 17, 2004)
  • K991618 — BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR (January 24, 2001)
  • K991276 — PASS/FAIL CHALLENGE PACK (July 12, 1999)
  • K973585 — PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR (November 6, 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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