VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS— 510(k) K864822

Name: FDA 510(k) clearance K864822
Creator: U.S. Food and Drug Administration
Published: 1987-01-15

Substantially Equivalent

Surgidyne, Inc.

FDA 510(k) clearance K864822 for VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS, Substantially Equivalent on 1987-01-15. Applicant: Surgidyne, Inc.. Device class: 1.

Clearance details

Applicant: Surgidyne, Inc.
Product code: Code BTC
Device class: Class 1
Regulation: 21 CFR 868.5320
Advisory panel: Anesthesiology
Date received: 1986-12-09
Decision date: 1987-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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