Cleared Traditional

BONE AND MARROW COLLECTION SYSTEM KIT

K971782 · Biomedical Ent., Inc. · General & Plastic Surgery

Jul 1997

Decision

76d

Days

Class 1

Risk

About This 510(k) Submission

K971782 is an FDA 510(k) clearance for the BONE AND MARROW COLLECTION SYSTEM KIT, 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 July 29, 1997, 76 days after receiving the submission on May 14, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K971782 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 1997
Decision Date	July 29, 1997
Days to Decision	76 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement