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510(k) K790077

BIOSTIL # 3884 by Venospital, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1979
Date Received
January 11, 1979
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 Venospital, Inc.

  • K791131 — FLU VEN TR-1 (September 4, 1979)
  • K791130 — FLU-VEN TK-2 (September 4, 1979)
  • K790424 — FLU-VEN 01510 (April 30, 1979)
  • K781190 — INFUSION SET, VENOTHIN 21 (August 10, 1978)
  • K781189 — FLU VEN 0151 (August 10, 1978)
  • K781186 — INFUSION, VENOTHIN 23 (August 10, 1978)
  • K781185 — INFUSION SET W/ INJECTION SITE (August 10, 1978)
  • K781187 — INFUSION SET W/ INJECTION SITE, 23D-W (August 10, 1978)
  • K781188 — INFUSION SET, VENOTHIN 25 (August 10, 1978)
  • K781184 — INFUSION SET, VENOTHIN 19 (August 10, 1978)

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