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510(k) K844512

DART DAILY AIR REMOVAL TEST by American Sterilizer Co. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1985
Date Received
November 20, 1984
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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  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)

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