Cleared Traditional

HYPODERMIC NEEDLE SHEATH HOLDER

K882405 · Ansr Ent., Inc. · General Hospital

Jun 1988

Decision

19d

Days

Class 2

Risk

About This 510(k) Submission

K882405 is an FDA 510(k) clearance for the HYPODERMIC NEEDLE SHEATH HOLDER, a Manometer, Spinal-fluid (Class II — Special Controls, product code FMJ), submitted by Ansr Ent., Inc. (Franktown, US). The FDA issued a Cleared decision on June 29, 1988, 19 days after receiving the submission on June 10, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2500.

Submission Details

510(k) Number	K882405 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 1988
Decision Date	June 29, 1988
Days to Decision	19 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—