SALINE SOLUTINE, STERILE— 510(k) K950560

Name: FDA 510(k) clearance K950560
Creator: U.S. Food and Drug Administration
Published: 1995-05-30

Substantially Equivalent

Busse Hospital Disposables, Inc.

FDA 510(k) clearance K950560 for SALINE SOLUTINE, STERILE, Substantially Equivalent on 1995-05-30. Applicant: Busse Hospital Disposables, Inc.. Device class: 1.

Clearance details

Applicant: Busse Hospital Disposables, Inc.
Product code: Code IGE
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1995-02-08
Decision date: 1995-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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