RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS

Accelerator, Linear, Medical

ORFIT INDUSTRIES

The following data is part of a premarket notification filed by Orfit Industries with the FDA for Raycast Immobilization Systems Hardware And Thermoplastic Materials.

Pre-market Notification Details

• Device ID: K991319
• 510k Number: K991319
• Device Name: RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS
• Classification: Accelerator, Linear, Medical
• Applicant: ORFIT INDUSTRIES 49 PLAIN ST. North Attleboro, MA 02760
• Contact: Cynthia Nolte
• Correspondent: Cynthia Nolte; ORFIT INDUSTRIES 49 PLAIN ST. North Attleboro, MA 02760
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-19
• Decision Date: 1999-09-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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