BOSTON BAND

Orthosis, Cranial

BOSTON BRACE INTL., INC.

The following data is part of a premarket notification filed by Boston Brace Intl., Inc. with the FDA for Boston Band.

Pre-market Notification Details

• Device ID: K111609
• 510k Number: K111609
• Device Name: BOSTON BAND
• Classification: Orthosis, Cranial
• Applicant: BOSTON BRACE INTL., INC. 20 LEDIN DR. Avon, MA 02322
• Contact: James Wynne
• Correspondent: James Wynne; BOSTON BRACE INTL., INC. 20 LEDIN DR. Avon, MA 02322
• Product Code: MVA
• CFR Regulation Number: 882.5970 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-09
• Decision Date: 2011-08-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860010708101	K111609	000