SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM— 510(k) K942495

Name: FDA 510(k) clearance K942495
Creator: U.S. Food and Drug Administration
Published: 1995-02-21

Substantially Equivalent

Atos Medical AB

FDA 510(k) clearance K942495 for SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM, Substantially Equivalent on 1995-02-21. 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: 1994-05-17
Decision date: 1995-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horby, Sweden, SE

Download summary PDF View on FDA.gov ↗

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