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510(k) K912612

SMOKE/ODOR EVACUATOR #757 by Olsen Electrosurgical, Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1991
Date Received
June 12, 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 Olsen Electrosurgical, Inc.

  • K922154 — INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION (April 21, 1994)
  • K912611 — OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE (April 15, 1992)
  • K913108 — TEFLON COATED ELECTRODES/ELECTRODES HANDLES (December 23, 1991)
  • K885200 — 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE (January 13, 1989)
  • K885199 — #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES (January 13, 1989)
  • K884172 — MODIFIED OLSEN #770 DISPOSABLE HOLSTER (October 24, 1988)
  • K884171 — #875 DISPOSABLE BIOPOLAR CABLE (October 24, 1988)
  • K884175 — #820/821 BIPOLAR FORCEPS (October 24, 1988)
  • K884174 — MODIFIED OLSEN 755/756 SWITCHPENS (October 24, 1988)
  • K884173 — #920 DISPOSABLE TUR CABLE (October 24, 1988)

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