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510(k) K140369

MEDLINE NEURO SPONGE by Medline Industries, Inc. — Product Code HBA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2014
Date Received
February 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Paddie
Device Class
Class II
Regulation Number
882.4700
Review Panel
NE
Submission Type

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  • K031008 — AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) (May 9, 2003)
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