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510(k) K930629

ACRYL-X II SYSTEM by Sonokinetics, Inc. — Product Code LZV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1994
Date Received
February 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Cement Removal Extraction
Device Class
Class II
Regulation Number
888.4580
Review Panel
OR
Submission Type

Other clearances by Sonokinetics, Inc.

  • K990572 — SONOTOME (May 21, 1999)
  • K911548 — ACRYL-X SYSTEM TM (June 28, 1991)

Other clearances for product code LZV

  • K021502 — OSCAR, MODEL OE3000 (June 6, 2002)
  • K961101 — STRYKER CEMENT REMOVAL SYSTEM (July 15, 1996)
  • K904156 — ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS (November 27, 1990)
  • K904180 — PROSTHETIC CEMENT REMOVER (November 20, 1990)
  • K891472 — IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR (May 2, 1989)
  • K890285 — PROSTHETIC CEMENT REMOVER (April 19, 1989)