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510(k) K922793

CEFZIL by Difco Laboratories, Inc. — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1992
Date Received
June 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type

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  • K944275 — DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. (December 19, 1994)
  • K941016 — DISPENS-O-DISC(TM) NITROCEFIN (June 30, 1994)

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