SILENT SLEEP

Device, Anti-snoring

CRANIOFACIAL PAIN CENTER OF IDAHO

The following data is part of a premarket notification filed by Craniofacial Pain Center Of Idaho with the FDA for Silent Sleep.

Pre-market Notification Details

• Device ID: K082849
• 510k Number: K082849
• Device Name: SILENT SLEEP
• Classification: Device, Anti-snoring
• Applicant: CRANIOFACIAL PAIN CENTER OF IDAHO 8119 USTICK ROAD Boise, ID 83704
• Contact: Jamison R Spencer
• Correspondent: Jamison R Spencer; CRANIOFACIAL PAIN CENTER OF IDAHO 8119 USTICK ROAD Boise, ID 83704
• Product Code: LRK
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-09-29
• Decision Date: 2009-07-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B14035301	K082849	000
B140351950	K082849	000
B140035201	K082849	000