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510(k) K921963

DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 by Sun Medical, Inc. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1992
Date Received
April 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

Other clearances by Sun Medical, Inc.

  • K911154 — SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200 (July 26, 1991)
  • K874948 — SUN MEDICAL SMOKE EVACUATOR SYSTEM (February 18, 1988)
  • K845006 — SUN MEDICAL LAMINARIA CERVICAL DILATOR (May 1, 1985)

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