3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90

System, Applicator, Radionuclide, Remote-controlled

VARIAN MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for 3d Interstitial Ring Applicator Set 60, 3d Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90.

Pre-market Notification Details

• Device ID: K150839
• 510k Number: K150839
• Device Name: 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90
• Classification: System, Applicator, Radionuclide, Remote-controlled
• Applicant: VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto, CA 94304
• Contact: Peter J. Coronado
• Correspondent: Peter J. Coronado; VARIAN MEDICAL SYSTEMS, INC. 911 HANSEN WAY Palo Alto, CA 94304
• Product Code: JAQ
• CFR Regulation Number: 892.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-03-30
• Decision Date: 2015-07-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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