CERVICAL BRACE

Component, Traction, Invasive

JEROME MEDICAL

The following data is part of a premarket notification filed by Jerome Medical with the FDA for Cervical Brace.

Pre-market Notification Details

• Device ID: K822780
• 510k Number: K822780
• Device Name: CERVICAL BRACE
• Classification: Component, Traction, Invasive
• Applicant: JEROME MEDICAL 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JEC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-09-14
• Decision Date: 1982-10-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05690977368958	K822780	000
05690977368941	K822780	000
05690977368934	K822780	000
05690977084469	K822780	000