MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)— 510(k) K041125

Name: FDA 510(k) clearance K041125
Creator: U.S. Food and Drug Administration
Published: 2004-12-30

Substantially Equivalent

Masep Med Science & Tech. Development (Shenzhen) C

FDA 510(k) clearance K041125 for MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM), Substantially Equivalent on 2004-12-30. Applicant: Masep Med Science & Tech. Development (Shenzhen) C. Device class: 2.

Clearance details

Applicant: Masep Med Science & Tech. Development (Shenzhen) C
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2004-04-30
Decision date: 2004-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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