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510(k) K834071

LYMPHANGIOGRAPHY SET SPECIAL 30G by Hyperion, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1984
Date Received
November 25, 1983
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 Hyperion, Inc.

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  • K935983 — MICROREADER 4 (December 9, 1994)
  • K913809 — HY-PREP SYSTEM (January 15, 1992)
  • K873138 — MICRO-READER II (September 14, 1987)
  • K864060 — MICRO-READER (November 28, 1986)
  • K855149 — COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER (February 11, 1986)

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