BUDDE-HALO RETRACTOR

Retractor, Self-retaining, For Neurosurgery

OHIO MEDICAL INSTRUMENT CO., INC.

The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for Budde-halo Retractor.

Pre-market Notification Details

• Device ID: K830332
• 510k Number: K830332
• Device Name: BUDDE-HALO RETRACTOR
• Classification: Retractor, Self-retaining, For Neurosurgery
• Applicant: OHIO MEDICAL INSTRUMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GZT
• CFR Regulation Number: 882.4800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-02-01
• Decision Date: 1983-03-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10381780538271	K830332	000
M268443A1070B1	K830332	000
M268443A1070C1	K830332	000
M268S443A10001	K830332	000
M268S443A10041	K830332	000
M268S443A1070B1	K830332	000
M268S438B11781	K830332	000
M268438A1077A1	K830332	000
M268438A1077C1	K830332	000
M268438A1077E1	K830332	000
M268438A1082A1	K830332	000
M268438A1082C1	K830332	000
M268438A1083A1	K830332	000
M268438A1083C1	K830332	000
M268438A1151A1	K830332	000
M268438A1151C1	K830332	000
M268438A11601	K830332	000
M268S443A1070C1	K830332	000
10381780542339	K830332	000
M268S438A1200B1	K830332	000
M268S443A1012A1	K830332	000
M268S443B10521	K830332	000
M268S438A10241	K830332	000
M268S438A10371	K830332	000
M268S438A11081	K830332	000
M268S438A11141	K830332	000
M268S438A11401	K830332	000
M268S438A11881	K830332	000
M268S438A1200A1	K830332	000
M268S438B10101	K830332	000
M268S443A10601	K830332	000
M268S443A1061A1	K830332	000
M268S443A1070A1	K830332	000
M268438A1152A1	K830332	000
M268438A1152C1	K830332	000
M268438A1151B1	K830332	000
M268438A1151D1	K830332	000
M268438A1152B1	K830332	000
M268438A1152D1	K830332	000
M268438A1154C1	K830332	000
M268438A1154E1	K830332	000
M268438A1155B1	K830332	000
M268438A1155D1	K830332	000
M268438A1157B1	K830332	000
M268438A1157D1	K830332	000
M268A1040A1	K830332	000
M268A10961	K830332	000
M268438A1192A1	K830332	000
M268438A1194A1	K830332	000
10381780533672	K830332	000
M268438A1083D1	K830332	000
M268438A1083B1	K830332	000
M268438A1154B1	K830332	000
M268438A1154D1	K830332	000
M268438A1155A1	K830332	000
M268438A1155C1	K830332	000
M268438A1157A1	K830332	000
M268438A1157C1	K830332	000
M268A10401	K830332	000
M268438A1192B1	K830332	000
M268438A1194B1	K830332	000
M268S438A11601	K830332	000
M268438A1077B1	K830332	000
M268438A1077D1	K830332	000
M268438A1077X1	K830332	000
M268438A1082B1	K830332	000
M268438A1082D1	K830332	000
10381780533689	K830332	000