HDR CT COMPATIBLE SPLIT RING APPLICATOR

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 Hdr Ct Compatible Split Ring Applicator.

Pre-market Notification Details

• Device ID: K063382
• 510k Number: K063382
• Device Name: HDR CT COMPATIBLE SPLIT RING APPLICATOR
• 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: 2006-11-08
• Decision Date: 2006-12-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817330021113	K063382	000
00817330022226	K063382	000
00817330022233	K063382	000
00817330022240	K063382	000
00817330022257	K063382	000
00817330022264	K063382	000
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00817330022288	K063382	000
00817330022295	K063382	000
00817330022301	K063382	000
00817330022318	K063382	000
00817330022325	K063382	000
00817330022332	K063382	000
00817330022349	K063382	000
00817330022356	K063382	000
00817330022363	K063382	000
00817330022370	K063382	000
00817330022219	K063382	000
00817330022202	K063382	000
00817330021120	K063382	000
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00817330021144	K063382	000
00817330021151	K063382	000
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00817330021175	K063382	000
00817330021182	K063382	000
00817330021199	K063382	000
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00817330023766	K063382	000
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00817330023797	K063382	000
00817330023803	K063382	000
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00817330023711	K063382	000
00817330023728	K063382	000
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00817330023933	K063382	000