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510(k) K921613

STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510 by Dept. of the Army — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1993
Date Received
April 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

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  • K894455 — DECONTAMINATING KIT, SKIN: M291 (August 15, 1989)

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