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510(k) K083012

PAPCONE by Otto Bock Pur Life Science GmbH — Product Code HHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2009
Date Received
October 9, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Spatula, Cervical, Cytological
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 (November 8, 2004)
  • K041018 — DRG SOFTRELEASE (October 18, 2004)