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510(k) K842498

DANIELL DBL PUNCTURE LASER LAPAROSCOPY by Laser Spectrum, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1984
Date Received
June 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

Other clearances by Laser Spectrum, Inc.

  • K863520 — CO2 LASER MICROMANIPULATOR (October 6, 1986)
  • K844765 — ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN (April 8, 1985)
  • K841781 — MODEL 305AA PORTABLE LASER (November 7, 1984)
  • K841668 — CO2 LAPAROSCOPE (April 23, 1984)

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