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510(k) K003443

SUCTION IRRIGATOR by Applied Medical — Product Code FHF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2001
Date Received
November 6, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Evacuator, Fluid
Device Class
Class II
Regulation Number
876.4370
Review Panel
GU
Submission Type

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Other clearances for product code FHF

  • K093479 — DISPOSABLE SUCTION AND IRRIGATION SYSTEM (May 19, 2010)
  • K771986 — CATHETER, MEDIASTINAL&PERICARDIAL (October 28, 1977)