CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR

System, Applicator, Radionuclide, Remote-controlled

MICK RADIO-NUCLEAR INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Ct Hdr Tandem/ring Applicator With Rectal Retractor.

Pre-market Notification Details

• Device ID: K030110
• 510k Number: K030110
• Device Name: CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
• Classification: System, Applicator, Radionuclide, Remote-controlled
• Applicant: MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon, NY 10550
• Contact: Felix Mick
• Correspondent: Felix Mick; MICK RADIO-NUCLEAR INSTRUMENTS, INC. 521 HOMESTEAD AVE. Mount Vernon, NY 10550
• Product Code: JAQ
• CFR Regulation Number: 892.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-01-13
• Decision Date: 2003-04-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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