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510(k) K772135

BIOLOGICAL/CHEMICAL INDICATOR by Amsco Co. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1977
Date Received
November 14, 1977
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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  • K831086 — CEILING MOUNTED SUPPORT (August 12, 1983)
  • K832186 — HALL DRILL/REAMER (August 12, 1983)
  • K831309 — DELIVERY 4 TABLE (June 15, 1983)
  • K823360 — SURGICAL LIGHT (December 3, 1982)

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