STARBAND

Orthosis, Cranial, Laser Scan

ORTHOMERICA PRODUCTS, INC.

The following data is part of a premarket notification filed by Orthomerica Products, Inc. with the FDA for Starband.

Pre-market Notification Details

• Device ID: K082950
• 510k Number: K082950
• Device Name: STARBAND
• Classification: Orthosis, Cranial, Laser Scan
• Applicant: ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL Orlando, FL 32810
• Contact: Alan T Sandifer
• Correspondent: Alan T Sandifer; ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL Orlando, FL 32810
• Product Code: OAN
• CFR Regulation Number: 882.5970 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-10-03
• Decision Date: 2008-12-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B151760PA0	K082950	000
B151703PA0	K082950	000
B15170406PA0	K082950	000
B151704PA0	K082950	000
B15170906PA0	K082950	000
B151709PA0	K082950	000
B15176006A0	K082950	000
B15176006PA0	K082950	000
B151760A0	K082950	000
B15170306PA0	K082950	000