P-POD

Orthosis, Cranial

P-POD

The following data is part of a premarket notification filed by P-pod with the FDA for P-pod.

Pre-market Notification Details

• Device ID: K133397
• 510k Number: K133397
• Device Name: P-POD
• Classification: Orthosis, Cranial
• Applicant: P-POD 7828 HICKORY FLAT HWY. SUITE 120 Woodstock, GA 30188
• Contact: Linda Braddon
• Correspondent: Linda Braddon; P-POD 7828 HICKORY FLAT HWY. SUITE 120 Woodstock, GA 30188
• Product Code: MVA
• CFR Regulation Number: 882.5970 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-06
• Decision Date: 2014-04-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00196852667895	K133397	000