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510(k) K991618

BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR by Propper Mfg. Co., Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2001
Date Received
May 11, 1999
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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  • K082620 — ONCE-A-DAY VERTOS TEST PACK (July 8, 2009)
  • K031152 — PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) (August 17, 2004)
  • 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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