Cleared Abbreviated

K100665 - MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
(FDA 510(k) Clearance)

K100665 · Needle Tech Products, Inc. · General Hospital

Jun 2010

Decision

108d

Days

Class 2

Risk

K100665 is an FDA 510(k) clearance for the MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Needle Tech Products, Inc. (Attleboro, US). The FDA issued a Cleared decision on June 24, 2010, 108 days after receiving the submission on March 8, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K100665 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2010
Decision Date	June 24, 2010
Days to Decision	108 days
Submission Type	Abbreviated
Review Panel	General Hospital (HO)
Summary	Statement