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510(k) K832739

STEDIFLO INFUSION SET by Dravon Medical, Inc. — Product Code LDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1983
Date Received
August 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Dravon Medical, Inc.

  • K873455 — S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS (September 14, 1987)
  • K860770 — AM-100 I/A AMPAC (April 21, 1986)
  • K831842 — DRAVON T CLAMP (September 26, 1983)
  • K812772 — PERITONEAL DIALYSIS CYCLER SET (8UNIT) (October 19, 1981)
  • K812771 — PERITONEAL DIALYSIS DRAINAGE (October 19, 1981)
  • K811851 — S-610 SHUNT ADAPTOR SET (August 31, 1981)
  • K800435 — HEMOSTATIC/TUBE OCCLUDING FORCEPS (March 12, 1980)
  • K782057 — CATHETER, RADIOPAQUE TENCKHOFF (February 27, 1979)
  • K782058 — CATHETER, BETA-CAP-PERITONEAL (February 27, 1979)
  • K781755 — DAP-PAK (February 15, 1979)

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