SATALEC SEPTOSONIC SC 80/SC 120— 510(k) K852527

Substantially Equivalent

Spelna, Inc.

FDA 510(k) clearance K852527 for SATALEC SEPTOSONIC SC 80/SC 120, Substantially Equivalent on 1986-01-03. Applicant: Spelna, Inc.. Device class: 1.

Clearance details

Applicant: Spelna, Inc.
Product code: Code FLG
Device class: Class 1
Regulation: 21 CFR 880.6150
Advisory panel: General Hospital
Date received: 1985-06-14
Decision date: 1986-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fredericksburg, VA, US

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Recent devices under product code FLG

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