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510(k) K871672

STERILIZATION INDICATOR FOR FLASH STERILIZATION by Propper Mfg. Co., Inc. — Product Code LRT

K871672 is an FDA 510(k) premarket notification submitted by Propper Mfg. Co., Inc. for the device "STERILIZATION INDICATOR FOR FLASH STERILIZATION". The FDA issued a decision of Substantially Equivalent on June 1, 1987. The device falls under product code LRT (Indicator, Sterilization), a Class II device regulated under 21 CFR 880.2800. Propper Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1987
Date Received
April 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Propper Mfg. Co., Inc.

  • K111453 — STEAM DOT BLU PROCESS INDICATOR (April 5, 2012)
  • K102894 — CLASSIX CHEMICAL STERILIZATION INDICATOR (May 25, 2011)
  • K082620 — ONCE-A-DAY VERTOS TEST PACK (July 8, 2009)
  • 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)
  • 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)

Other clearances for product code LRT

  • K002937 — TST CONTROL INTEGRATOR FOR STEAM STERILIZERS (November 5, 2001)
  • K965154 — TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE (September 19, 1997)
  • K951113 — CROSS-CHECKS (August 19, 1996)
  • K951703 — TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS (June 28, 1995)

FDA data resources