EQUIPMENT SNAP KOVERS

System, X-ray, Fluoroscopic, Image-intensified

ADVANCE MEDICAL DESIGNS, INC.

The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Equipment Snap Kovers.

Pre-market Notification Details

• Device ID: K850959
• 510k Number: K850959
• Device Name: EQUIPMENT SNAP KOVERS
• Classification: System, X-ray, Fluoroscopic, Image-intensified
• Applicant: ADVANCE MEDICAL DESIGNS, INC. 1400 MARIETTA PARKWAY, SU 105 Marietta, GA 30067
• Contact: Joseph R Cottone
• Correspondent: Joseph R Cottone; ADVANCE MEDICAL DESIGNS, INC. 1400 MARIETTA PARKWAY, SU 105 Marietta, GA 30067
• Product Code: JAA
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-03-08
• Decision Date: 1985-04-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10848340002295	K850959	000
10848340020169	K850959	000
10848340010153	K850959	000
10848340009935	K850959	000
10848340019149	K850959	000
10848340017176	K850959	000
10848340012638	K850959	000
10848340020213	K850959	000
10848340009959	K850959	000
10848340009942	K850959	000
10848340020237	K850959	000
10848340020220	K850959	000
10848340009966	K850959	000
10848340009782	K850959	000
10848340020176	K850959	000
10848340020183	K850959	000
10848340020206	K850959	000
10848340019095	K850959	000
10848340002332	K850959	000
10848340013123	K850959	000
10848340002417	K850959	000
10848340002400	K850959	000
10848340002349	K850959	000
10848340013062	K850959	000
10848340012669	K850959	000
10848340012096	K850959	000
10848340020145	K850959	000
10848340012690	K850959	000
10848340012683	K850959	000
10848340012676	K850959	000
10848340020268	K850959	000
10848340020251	K850959	000
10848340019101	K850959	000
10848340006705	K850959	000
10848340010245	K850959	000
10848340010238	K850959	000
10848340010290	K850959	000
10848340010283	K850959	000
10848340010276	K850959	000
10848340010320	K850959	000
10848340010306	K850959	000
10848340010160	K850959	000
10848340015486	K850959	000
10848340012089	K850959	000
10848340011464	K850959	000
10848340019118	K850959	000
10848340009812	K850959	000
10848340015417	K850959	000
10848340010009	K850959	000
10848340011457	K850959	000
10848340011440	K850959	000
10848340011433	K850959	000
10848340020299	K850959	000
10848340020282	K850959	000
10848340020275	K850959	000
10848340020305	K850959	000
10848340009928	K850959	000
10848340005500	K850959	000
10848340002363	K850959	000
10848340002356	K850959	000
10848340020329	K850959	000
10848340010481	K850959	000
10848340002318	K850959	000
10848340007993	K850959	000
10848340018975	K850959	000
10848340018753	K850959	000
10848340008747	K850959	000
10848340014878	K850959	000
10848340005913	K850959	000
10848340005531	K850959	000
10848340014670	K850959	000
10848340014618	K850959	000
10848340013543	K850959	000
10848340018012	K850959	000
10848340016742	K850959	000
10848340014663	K850959	000
10848340012928	K850959	000
10848340005906	K850959	000
10848340009638	K850959	000
10848340009805	K850959	000
10848340007214	K850959	000
10848340002202	K850959	000
10848340002196	K850959	000
10848340002189	K850959	000
20848340002384	K850959	000
10848340002301	K850959	000
10848340015400	K850959	000
10848340013055	K850959	000
10848340015424	K850959	000
10848340006545	K850959	000
10848340014571	K850959	000
10848340005449	K850959	000
10848340009904	K850959	000
10848340006071	K850959	000
10848340009874	K850959	000
10848340005463	K850959	000
10848340002240	K850959	000
10848340002233	K850959	000
10848340020114	K850959	000
10848340020107	K850959	000
10848340002264	K850959	000
10848340002257	K850959	000
10848340015431	K850959	000
10848340005487	K850959	000
10848340005470	K850959	000
10848340002288	K850959	000
10848340018241	K850959	000
10848340012942	K850959	000
10848340002226	K850959	000
10848340005524	K850959	000
10848340020091	K850959	000
10848340009881	K850959	000
10848340019798	K850959	000
10848340019781	K850959	000
10848340020039	K850959	000
10848340020022	K850959	000
10848340016865	K850959	000
10848340017022	K850959	000
10848340013079	K850959	000
10848340009621	K850959	000
10848340019880	K850959	000
10848340020084	K850959	000
10848340010030	K850959	000
10848340002219	K850959	000
10848340002325	K850959	000