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
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