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510(k) K883522

AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT by Amerimed US Corp. — Product Code LBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1988
Date Received
August 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Ultrasonic Instruments
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

Other clearances by Amerimed US Corp.

  • K891722 — LATEX EXAM GLOVES (MFG. SHANGHAI MEHECO) (July 14, 1989)
  • K891437 — PATIENT EXAMINATION GLOVES (LATEX) (May 31, 1989)
  • K891436 — PATIENT EXAMINATION GLOVES (LATEX) (May 31, 1989)
  • K890967 — VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX) (May 4, 1989)

Other clearances for product code LBK

  • K972612 — DISSECTRON PORTABLE UNIT (October 8, 1997)
  • K962952 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) (November 29, 1996)
  • K884412 — CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. (December 2, 1988)
  • K884413 — CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR (December 2, 1988)
  • K855138 — BOVIE ULTRASONIC SURGICAL SYSTEM (November 10, 1986)
  • K853143 — COOPER LASER SONICS CUSA MODEL 200 (October 16, 1985)