OSIRIS

Accelerator, Linear, Medical

HUESTIS MEDICAL

The following data is part of a premarket notification filed by Huestis Medical with the FDA for Osiris.

Pre-market Notification Details

• Device ID: K981153
• 510k Number: K981153
• Device Name: OSIRIS
• Classification: Accelerator, Linear, Medical
• Applicant: HUESTIS MEDICAL 68 BUTTONWOOD ST. PO BOX 718 Bristol, RI 02807 -0718
• Contact: Terry Chwalk
• Correspondent: Terry Chwalk; HUESTIS MEDICAL 68 BUTTONWOOD ST. PO BOX 718 Bristol, RI 02807 -0718
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-03-30
• Decision Date: 1999-03-17