Cleared Special

AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE

K052528 · Ceremed , Inc. · General & Plastic Surgery
Oct 2005
Decision
27d
Days
Risk

About This 510(k) Submission

K052528 is an FDA 510(k) clearance for the AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE, a Wax, Bone, submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 11, 2005, 27 days after receiving the submission on September 14, 2005. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K052528 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2005
Decision Date October 11, 2005
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code MTJ — Wax, Bone
Device Class

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