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510(k) K981041

SLT BIPOLAR SHEATH by Surgical Laser Technologies, Inc. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1998
Date Received
March 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

Other clearances by Surgical Laser Technologies, Inc.

  • K042211 — MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS (November 8, 2004)
  • K023624 — SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-676 (January 27, 2003)
  • K011409 — SLT LASERPRO CTH HOLMIUM LASER SYSTEM (June 14, 2001)
  • K010041 — SLT DIFFUSER FIBER (March 7, 2001)
  • K984018 — HEMOSLEEVE, MODEL 4.0MM, 5.5MM (March 15, 1999)
  • K983050 — PNEUMATIC CUTTER SYSTEM (November 25, 1998)
  • K972548 — SLT CL MD CONTACT LASER SYSTEM (April 21, 1998)
  • K980156 — SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS (February 27, 1998)
  • K960821 — SLT FUMICH PROBE GUIDE (May 16, 1996)
  • K954727 — SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION) (February 5, 1996)

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