Cleared Traditional

BONE & MARROW COLLECTION SYSTEM

K961901 · Biomedical Ent., Inc. · General & Plastic Surgery

Aug 1996

Decision

82d

Days

Class 1

Risk

About This 510(k) Submission

K961901 is an FDA 510(k) clearance for the BONE & MARROW COLLECTION SYSTEM, a Motor, Surgical Instrument, Ac-powered (Class I — General Controls, product code GEY), submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on August 6, 1996, 82 days after receiving the submission on May 16, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K961901 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 1996
Decision Date	August 06, 1996
Days to Decision	82 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement