HS AMICA

System, Ablation, Microwave And Accessories

H.S HOSPITAL SERVICE S.P.A.

The following data is part of a premarket notification filed by H.s Hospital Service S.p.a. with the FDA for Hs Amica.

Pre-market Notification Details

• Device ID: K083157
• 510k Number: K083157
• Device Name: HS AMICA
• Classification: System, Ablation, Microwave And Accessories
• Applicant: H.S HOSPITAL SERVICE S.P.A. 6600 W. ROGERS CIRCLE SUITES 1 & 2 Boca Raton, FL 33487
• Contact: Lucio Improta
• Correspondent: Lucio Improta; H.S HOSPITAL SERVICE S.P.A. 6600 W. ROGERS CIRCLE SUITES 1 & 2 Boca Raton, FL 33487
• Product Code: NEY
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-10-24
• Decision Date: 2009-09-29
• Summary: summary