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510(k) K882105

CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM by Dianon Systems, Inc. — Product Code GAA

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
July 11, 1988
Date Received
May 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Dianon Systems, Inc.

  • K872597 — FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE (July 28, 1987)

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