Cleared Traditional

K950560 - SALINE SOLUTINE, STERILE
(FDA 510(k) Clearance)

K950560 · Busse Hospital Disposables, Inc. · Pathology
May 1995
Decision
111d
Days
Class 1
Risk

K950560 is an FDA 510(k) clearance for the SALINE SOLUTINE, STERILE, a Solution, Formalin Ammonium Bromide (Class I — General Controls, product code IGE), submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on May 30, 1995, 111 days after receiving the submission on February 8, 1995. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K950560 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1995
Decision Date May 30, 1995
Days to Decision 111 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement

Device Classification

Product Code IGE — Solution, Formalin Ammonium Bromide
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010