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510(k) K843514

MINUTEMAN CO2 MICROSURGICAL LASER OTO by American Surgical Laser, Inc. — Product Code EWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1984
Date Received
September 5, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ent Microsurgical Carbon-Dioxide
Device Class
Class II
Regulation Number
874.4500
Review Panel
EN
Submission Type

Other clearances by American Surgical Laser, Inc.

  • K843515 — MINUTEMAN CO2 MICROSURGICAL LASER GYN (February 4, 1985)
  • K843517 — MINUTEMAN CO2 MICROSURG LASER DERMATOL- (December 7, 1984)
  • K843518 — MINUTEMAN C02 MICROSURG LASER PODIATRY (December 7, 1984)
  • K843519 — MINUTEMAN CO2 MICROSURG LASER GEN SURG (December 7, 1984)

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  • K880427 — ILLUMINA 40 CO2 LASER SYSTEM (April 18, 1988)
  • K880429 — ILLUMINA 55 CO2 LASER SYSTEM (April 18, 1988)
  • K872710 — MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT (September 24, 1987)
  • K870840 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH (June 12, 1987)
  • K864975 — LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) (February 25, 1987)
  • K862865 — MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE (January 9, 1987)
  • K862866 — MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE (January 9, 1987)