SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS— 510(k) K922145

Name: FDA 510(k) clearance K922145
Creator: U.S. Food and Drug Administration
Published: 1993-01-21

Substantially Equivalent

Atos Medical AB

FDA 510(k) clearance K922145 for SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS, Substantially Equivalent on 1993-01-21. Applicant: Atos Medical AB. Device class: 1.

Clearance details

Applicant: Atos Medical AB
Product code: Code KAM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1992-05-07
Decision date: 1993-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

Download summary PDF View on FDA.gov ↗

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