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510(k) K924681

GLUTARALDEHYDE MONITORS by Pymah Corp. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1993
Date Received
September 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Pymah Corp.

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  • 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)
  • K925744 — TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF (July 30, 1993)
  • K930604 — BALANCED(TM) NYLON BLADDER (April 30, 1993)

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