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510(k) K844087

XANAR MODEL XSE-300 SMOKE EVACULATER by Xanar, Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1985
Date Received
October 22, 1984
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 Xanar, Inc.

  • K861688 — XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 (October 3, 1986)
  • K852436 — AMBULASE (April 18, 1986)
  • K860496 — MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY (March 14, 1986)
  • K853620 — MODEL XA-50 - CO2 SURGICAL LASER (January 24, 1986)
  • K850818 — CO 2 SURGICAL LASER SYSTEM NA-120 (August 15, 1985)
  • K850805 — CO 2 SURGICAL LASER SYSTEM MODEL NA-40 (August 15, 1985)
  • K850804 — CO 2 SURGICAL LASER SYSTEM NA-30 (August 15, 1985)
  • K841860 — CO2 SURGICAL LASER SYSTEM XML-10 (November 8, 1984)
  • K833325 — AMBULASE XAM-15 XANAR SURG. LASER (January 26, 1984)
  • K837224 — UNKNOWN (May 2, 1983)

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