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510(k) K802634

STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. by Organon, Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1980
Date Received
October 22, 1980
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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  • K831109 — DUOCLON SLIDE TEST (June 2, 1983)
  • K823682 — BETA FFIRM TEST (January 7, 1983)

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