ISIS

Unit, Cryosurgical, Accessories

GALIL MEDICAL LTD.

The following data is part of a premarket notification filed by Galil Medical Ltd. with the FDA for Isis.

Pre-market Notification Details

• Device ID: K070482
• 510k Number: K070482
• Device Name: ISIS
• Classification: Unit, Cryosurgical, Accessories
• Applicant: GALIL MEDICAL LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004
• Contact: Jonathan S Kahan
• Correspondent: Jonathan S Kahan; GALIL MEDICAL LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004
• Product Code: GEH
• CFR Regulation Number: 878.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-20
• Decision Date: 2007-03-20
• Summary: summary