GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM

System, Applicator, Radionuclide, Remote-controlled

GAMMAMED USA

The following data is part of a premarket notification filed by Gammamed Usa with the FDA for Gammamed Plus High Dose Rate Remote Afterloading System.

Pre-market Notification Details

• Device ID: K983436
• 510k Number: K983436
• Device Name: GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
• Classification: System, Applicator, Radionuclide, Remote-controlled
• Applicant: GAMMAMED USA 2464 EAST STADIUM WAY Ann Arbor, MI 48104
• Contact: John J Munro Iii
• Correspondent: John J Munro Iii; GAMMAMED USA 2464 EAST STADIUM WAY Ann Arbor, MI 48104
• Product Code: JAQ
• CFR Regulation Number: 892.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-09-29
• Decision Date: 1998-10-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816389022812	K983436	000
00816389022409	K983436	000
00816389022393	K983436	000
00816389022386	K983436	000
00816389022379	K983436	000
00816389022362	K983436	000
00816389022355	K983436	000
00816389022348	K983436	000
00816389022317	K983436	000
00816389022300	K983436	000
00816389022294	K983436	000
00816389022287	K983436	000
00816389022270	K983436	000
00816389022263	K983436	000
00816389022416	K983436	000
00816389022430	K983436	000
00816389022805	K983436	000
00816389022799	K983436	000
00816389022744	K983436	000
00816389022737	K983436	000
00816389022720	K983436	000
00816389022713	K983436	000
00816389022621	K983436	000
00816389022607	K983436	000
00816389022515	K983436	000
00816389022508	K983436	000
00816389022492	K983436	000
00816389022478	K983436	000
00816389022447	K983436	000
00816389022256	K983436	000
00816389022195	K983436	000
00816389021822	K983436	000
00816389029187	K983436	000
00816389029170	K983436	000
00816389029163	K983436	000
00816389029156	K983436	000
00816389029149	K983436	000
00816389029132	K983436	000
00816389029125	K983436	000
00816389029118	K983436	000
00816389029101	K983436	000
00816389029095	K983436	000
00816389029088	K983436	000
00816389029071	K983436	000
00816389029064	K983436	000
00816389029194	K983436	000
00816389021488	K983436	000
00816389021778	K983436	000
00816389021761	K983436	000
00816389021754	K983436	000
00816389021747	K983436	000
00816389021730	K983436	000
00816389021723	K983436	000
00816389021716	K983436	000
00816389021709	K983436	000
00816389021693	K983436	000
00816389021686	K983436	000
00816389021662	K983436	000
00816389021655	K983436	000
00816389021617	K983436	000
10816389024646	K983436	000
00816389022829	K983436	000
00816389025189	K983436	000
00816389024502	K983436	000
00816389024496	K983436	000
00816389024489	K983436	000
00816389024441	K983436	000
00816389024434	K983436	000
00816389024427	K983436	000
00816389024410	K983436	000
00816389024403	K983436	000
00816389024397	K983436	000
00816389024380	K983436	000
00816389024373	K983436	000
00816389024366	K983436	000
00816389024359	K983436	000
00816389024519	K983436	000
00816389024526	K983436	000
00816389025172	K983436	000
00816389025158	K983436	000
00816389025141	K983436	000
00816389024946	K983436	000
00816389024939	K983436	000
00816389024922	K983436	000
00816389024915	K983436	000
00816389024908	K983436	000
00816389024892	K983436	000
00816389024885	K983436	000
00816389024878	K983436	000
00816389024861	K983436	000
00816389024533	K983436	000
00816389024342	K983436	000
00816389024335	K983436	000
00816389024328	K983436	000
00816389023475	K983436	000
00816389023413	K983436	000
00816389023277	K983436	000
00816389023260	K983436	000
00816389023253	K983436	000
00816389023246	K983436	000
00816389023239	K983436	000
00816389023222	K983436	000
00816389023208	K983436	000
00816389023161	K983436	000
00816389022959	K983436	000
00816389022935	K983436	000
00816389022898	K983436	000
00816389023604	K983436	000
00816389023659	K983436	000
00816389024304	K983436	000
00816389023956	K983436	000
00816389023949	K983436	000
00816389023932	K983436	000
00816389023925	K983436	000
00816389023918	K983436	000
00816389023901	K983436	000
00816389023871	K983436	000
00816389023864	K983436	000
00816389023857	K983436	000
00816389023840	K983436	000
00816389023802	K983436	000
00816389023666	K983436	000
00816389022874	K983436	000