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510(k) K961148

CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) by Difco Laboratories, Inc. — Product Code JTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1996
Date Received
March 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Transport, Aerobic
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

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  • K941016 — DISPENS-O-DISC(TM) NITROCEFIN (June 30, 1994)
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