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510(k) K911154

SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 by Sun Medical, Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1991
Date Received
March 15, 1991
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

Other clearances by Sun Medical, Inc.

  • K921963 — DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 (September 11, 1992)
  • K874948 — SUN MEDICAL SMOKE EVACUATOR SYSTEM (February 18, 1988)
  • K845006 — SUN MEDICAL LAMINARIA CERVICAL DILATOR (May 1, 1985)

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