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510(k) K073576

NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES by Harod Enterprises, Inc. — Product Code HBA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2008
Date Received
December 19, 2007
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

Other clearances for product code HBA

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  • K121822 — DELICOT (September 10, 2012)
  • 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)
  • K014268 — NORAPAD PLAIN; NORAPAD TA (March 27, 2002)
  • K993019 — PACIFIC SURGICAL PATTIES (March 30, 2000)
  • K973083 — ULTRACELL NEURO SPONGES (December 9, 1997)