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510(k) K981541

CLEARSTAR ENTERAL NUTRITION PUMP by Frantz Medical Development, Ltd. — Product Code LZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1998
Date Received
April 29, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Enteral
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Frantz Medical Development, Ltd.

  • K905282 — ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE (March 19, 1991)
  • K873119 — FLEXIFLO COMPANION ENTERAL NUTRITION PUMP (November 5, 1987)
  • K871710 — BIOPSY FORCEPS (August 10, 1987)
  • K863508 — FRANTZ MEDICAL ELECTRODE (February 6, 1987)

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