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510(k) K904156

ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS by Origin Medsystems, Inc. — Product Code LZV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1990
Date Received
September 7, 1990
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

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  • K962104 — AIRLIFT BALLOON RETRACTON SYSTEM (September 11, 1996)
  • K962005 — EXTRAHAND BALLOON RETRACTOR (August 12, 1996)
  • K960936 — RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] (July 24, 1996)
  • K960637 — 5MM ENDOSCOPE (June 14, 1996)

Other clearances for product code LZV

  • K021502 — OSCAR, MODEL OE3000 (June 6, 2002)
  • K961101 — STRYKER CEMENT REMOVAL SYSTEM (July 15, 1996)
  • K930629 — ACRYL-X II SYSTEM (January 21, 1994)
  • K904180 — PROSTHETIC CEMENT REMOVER (November 20, 1990)
  • K891472 — IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR (May 2, 1989)
  • K890285 — PROSTHETIC CEMENT REMOVER (April 19, 1989)