Home / 510(k) Clearances / K915170

510(k) K915170

PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR by Pymah Corp. — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1992
Date Received
November 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilant, Medical Devices
Device Class
Class II
Regulation Number
880.6885
Review Panel
HO
Submission Type

Other clearances by Pymah Corp.

  • K952995 — ATI ETHYLENE OXIDE STERILIZATION INDICATOR (February 22, 1996)
  • K952408 — ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION (July 6, 1995)
  • K951063 — ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION (May 10, 1995)
  • K934874 — STERIGAGE EO 100% (April 18, 1995)
  • K943081 — TRIMLINE 2000 (January 27, 1995)
  • K925496 — ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK (February 1, 1994)
  • K925745 — ATI(R) DISP BIOLOGICAL-PLUS TEST PACK (February 1, 1994)
  • K934180 — SLIMLINE 3000 (November 24, 1993)
  • K924681 — GLUTARALDEHYDE MONITORS (November 17, 1993)
  • K925744 — TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF (July 30, 1993)

Other clearances for product code MED

  • K232914 — SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liq (October 3, 2023)
  • K230582 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (March 28, 2023)
  • K222615 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (September 28, 2022)
  • K211607 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (September 7, 2021)
  • K210737 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (May 12, 2021)
  • K192929 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (December 10, 2019)
  • K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 (September 5, 2019)
  • K190104 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chem (March 22, 2019)
  • K182827 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (January 31, 2019)
  • K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System (April 4, 2018)