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510(k) K894398

STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE by Pymah Corp. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1989
Date Received
July 17, 1989
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 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)

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