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510(k) K952995

ATI ETHYLENE OXIDE STERILIZATION INDICATOR by Pymah Corp. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1996
Date Received
June 28, 1995
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

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  • 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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