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510(k) K842289

SR- MODEL 230 by Hirata Sangyo Co. USA, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1984
Date Received
June 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Hirata Sangyo Co. USA, Inc.

  • K864106 — SR-MODEL 230 (MODIFICATION) (November 19, 1986)
  • K833541 — SURGICAL INSTRUMENT (November 28, 1983)
  • K833542 — SURGICAL INSTRUMENT (November 28, 1983)
  • K832686 — MULTIPLE MANUAL SURGICAL INSTRUMENTS (October 14, 1983)
  • K831583 — GP-303 (July 19, 1983)
  • K821989 — NON-STETHO 7, UM-15TP (October 18, 1982)
  • K822571 — SYRINGE PUMP (October 8, 1982)

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