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510(k) K832686

MULTIPLE MANUAL SURGICAL INSTRUMENTS by Hirata Sangyo Co. USA, Inc. — Product Code HTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
August 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reamer
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Hirata Sangyo Co. USA, Inc.

  • K864106 — SR-MODEL 230 (MODIFICATION) (November 19, 1986)
  • K842289 — SR- MODEL 230 (July 25, 1984)
  • K833542 — SURGICAL INSTRUMENT (November 28, 1983)
  • K833541 — SURGICAL INSTRUMENT (November 28, 1983)
  • K831583 — GP-303 (July 19, 1983)
  • K821989 — NON-STETHO 7, UM-15TP (October 18, 1982)
  • K822571 — SYRINGE PUMP (October 8, 1982)

Other clearances for product code HTO

  • K111437 — SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) (August 10, 2011)
  • K042899 — SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS (March 16, 2005)
  • K013527 — MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM (December 21, 2001)
  • K993335 — SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM (June 12, 2000)
  • K954915 — FLEXIBLE INTRAMEDULLARY REAMER (December 28, 1995)
  • K903248 — COMBINATION REAMER (July 30, 1990)
  • K885100 — MCCONNELL REAMER GUIDE (January 13, 1989)
  • K870845 — WARSAW ORTHOPEDIC POINTED REAMER (March 11, 1987)
  • K862933 — ABC-1000 SMALL JOINT REAMERS (August 18, 1986)
  • K811081 — MEDULLARY CANAL SCRAPERS (April 29, 1981)