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510(k) K915067

DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS by American Medical Corp. — Product Code MMK

Clearance Details

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

Device Classification

Device Name
Container, Sharps
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by American Medical Corp.

  • K922493 — AMERICAN MEDICAL MFG. LUMBAR CPM (July 27, 1992)
  • K910214 — AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS (April 25, 1991)

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