Cleared Traditional

BIOACCESS MARROW HARVEST SYSTEM

K953064 · Bioaccess, Inc. · General & Plastic Surgery

Aug 1995

Decision

38d

Days

Class 1

Risk

About This 510(k) Submission

K953064 is an FDA 510(k) clearance for the BIOACCESS MARROW HARVEST SYSTEM, a Needle, Aspiration And Injection, Reusable (Class I — General Controls, product code GDM), submitted by Bioaccess, Inc. (Silver Spring, US). The FDA issued a Cleared decision on August 7, 1995, 38 days after receiving the submission on June 30, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K953064 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 1995
Decision Date	August 07, 1995
Days to Decision	38 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF