PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM

Accelerator, Linear, Medical

BIONIX DEVELOPMENT CORP.

The following data is part of a premarket notification filed by Bionix Development Corp. with the FDA for Pelvis Bellyboard Plus Patient Positioning System.

Pre-market Notification Details

• Device ID: K040773
• 510k Number: K040773
• Device Name: PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM
• Classification: Accelerator, Linear, Medical
• Applicant: BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612
• Contact: James Huttner
• Correspondent: Ned E Devine; ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2004-03-26
• Decision Date: 2004-04-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10817740020024	K040773	000
00714646000316	K040773	000
00714646000293	K040773	000
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10714646001235	K040773	000
10714646001228	K040773	000
10714646001211	K040773	000
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10714646001198	K040773	000
00714646001276	K040773	000
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10714646000375	K040773	000
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10714646000344	K040773	000
00714646001269	K040773	000
00817740021178	K040773	000
00817740020799	K040773	000
00817740020782	K040773	000
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00817740020768	K040773	000
00817740020751	K040773	000
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00817740020843	K040773	000
00817740020836	K040773	000
00817740020706	K040773	000
00817740020690	K040773	000
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00817740020140	K040773	000
00817740020133	K040773	000
00817740020119	K040773	000
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10817740020055	K040773	000
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00817740020652	K040773	000
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00817740020621	K040773	000
00817740020614	K040773	000
00817740020607	K040773	000
10817740020031	K040773	000