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510(k) K052735

ALLOCRAFT DBM by Lifecell Corp. — Product Code MBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2005
Date Received
September 30, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

Other clearances by Lifecell Corp.

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  • K082176 — LTM-BPS SURGICAL MESH (November 14, 2008)
  • K082103 — LTM WOUND DRESSING (October 8, 2008)
  • K080353 — LTM-T SURGICAL MESH (April 3, 2008)
  • K071986 — LTM-RC SURGICAL MESH (October 19, 2007)
  • K070560 — LRTM SURGICAL MESH (June 11, 2007)
  • K061208 — LIFECELL DURAL SUBSTITUTE MATRIX (January 3, 2007)

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  • K080399 — DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (October 10, 2008)
  • K081817 — ACCELL TBM-R (September 24, 2008)