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510(k) K952981

FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC by Utah Medical Products, Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1995
Date Received
June 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

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  • K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
  • K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER (February 10, 1997)

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