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510(k) K945796

SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM by Sharplan Lasers, Inc. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1995
Date Received
November 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Sharplan Lasers, Inc.

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  • K971874 — SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) (August 18, 1997)
  • K971648 — SHARPLAN ERBIUM: YAG LASER (4020) (July 23, 1997)
  • K971743 — SHARPLAN CO2 SURGICAL LASER SYSTEM (July 18, 1997)
  • K962446 — SHARPLAN RUBY LASER SYSTEM (March 7, 1997)
  • K963229 — SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS (November 5, 1996)
  • K961935 — SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER (November 1, 1996)
  • K962974 — SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) (August 21, 1996)
  • K961279 — SHARPLAN LASERS, INC. RUBY LASER SYSTEM (June 18, 1996)

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