ASPISAFE GASTRIC TUBE— 510(k) K961711

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K961711 for ASPISAFE GASTRIC TUBE, Substantially Equivalent on 1997-06-11. Applicant: B.Braun Medical, Inc.. Device class: 2.

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code BSS
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1996-05-02
Decision date: 1997-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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