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510(k) K910695

AUTO SASH (TM) by Block Medical, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1991
Date Received
February 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Block Medical, Inc.

  • K944692 — C-SERIES HOMEPUMP (May 2, 1995)
  • K940117 — MID-500 (June 10, 1994)
  • K934551 — VERIFUSE AMBULATORY PUMP (March 17, 1994)
  • K935236 — FLOW CONTROLLING EXTENSION SET (February 24, 1994)
  • K932740 — HOMEPUMP NSF (October 6, 1993)
  • K904663 — AUTO SASH (TM) (November 23, 1992)
  • K914924 — CHEMO PRIMING PIN(TM) (March 6, 1992)
  • K914855 — MULTIPLE DOSE CONTROLLER (January 24, 1992)
  • K914854 — THUMPER (January 24, 1992)
  • K902891 — VERIFUSE AMBULATORY PUMP (November 21, 1990)

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