DISPOSABLE FLEX TUBE— 510(k) K954197

Substantially Equivalent

Engstrom Medical

FDA 510(k) clearance K954197 for DISPOSABLE FLEX TUBE, Substantially Equivalent on 1995-10-26. Applicant: Engstrom Medical. Device class: 1.

Clearance details

Applicant: Engstrom Medical
Product code: Code BZA
Device class: Class 1
Regulation: 21 CFR 868.5810
Advisory panel: Anesthesiology
Date received: 1995-09-06
Decision date: 1995-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S-161 02 Bromma, SE

Download summary PDF View on FDA.gov ↗

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