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510(k) K915065

I.V.IRRIGATION POLE by American Medical Mfg., Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1992
Date Received
November 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by American Medical Mfg., Inc.

  • K982029 — SHARPS COLLECTION CONTAINER - SAF-T-SHELL (April 6, 1999)
  • K961454 — AMMI MAGNI-GUARD (July 25, 1996)
  • K915066 — DISPOSABLE SKIN MARKER (May 14, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K915068 — PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER (February 6, 1992)

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