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510(k) K121953

HEMASORB APPLY by Orthocon, Inc. — Product Code MTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2012
Date Received
July 3, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wax, Bone
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

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  • K202363 — HBP7 Settable Hemostatic Bone Putty (January 19, 2021)
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  • K191140 — MONTAGE-QS Settable, Resorbable Hemostatic Bone (July 18, 2019)
  • K153317 — HEMASORBPLUS Resorbable Hemostatic Bone Putty (November 30, 2016)
  • K153095 — ROP Resorbable Hemostasis Material (February 17, 2016)