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510(k) K864106

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1986
Date Received
October 21, 1986
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.

  • K842289 — SR- MODEL 230 (July 25, 1984)
  • 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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