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510(k) K071776

ANEUROPLASTIC, MODEL 43-1290 by Codman & Shurtleff, Inc. — Product Code JXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2007
Date Received
June 29, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Aneurysmorrhaphy
Device Class
Class II
Regulation Number
882.5030
Review Panel
NE
Submission Type

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Other clearances for product code JXH

  • K882072 — ORTHOPAEDIC AND SPINAL RING CURRETTES (June 17, 1988)
  • K873688 — ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL (October 26, 1987)