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510(k) K014268

NORAPAD PLAIN; NORAPAD TA by Perlei Medical, Inc. — Product Code HBA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2002
Date Received
December 27, 2001
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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  • K121822 — DELICOT (September 10, 2012)
  • K073576 — NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES (February 22, 2008)
  • K062406 — AESCULAP NEURO PATTIES (September 15, 2006)
  • K031008 — AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) (May 9, 2003)
  • K020736 — TRAATEK COTTONOID PATTIES (June 3, 2002)
  • K993019 — PACIFIC SURGICAL PATTIES (March 30, 2000)
  • K973083 — ULTRACELL NEURO SPONGES (December 9, 1997)