Cleared Traditional

K000021 - AESCULAP BONE WAX (FDA 510(k) Clearance)

K000021 · Aesculap, Inc. · General & Plastic Surgery device

Mar 2000

Decision

80d

Days

—

Risk

K000021 is an FDA 510(k) clearance for the AESCULAP BONE WAX. This device is classified as a Wax, Bone.

Submitted by Aesculap, Inc. (San Diego, US). The FDA issued a Cleared decision on March 24, 2000, 80 days after receiving the submission on January 4, 2000.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K000021 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 04, 2000
Decision Date	March 24, 2000
Days to Decision	80 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF