The following data is part of a premarket notification filed by Cranial Technologies, Inc. with the FDA for Doc Band.
Device ID | K014012 |
510k Number | K014012 |
Device Name: | DOC BAND |
Classification | Orthosis, Cranial, Laser Scan |
Applicant | CRANIAL TECHNOLOGIES, INC. 1395 WEST AUTO DR. Tempe, AZ 85284 |
Contact | Timothy R Littlefield |
Correspondent | Timothy R Littlefield CRANIAL TECHNOLOGIES, INC. 1395 WEST AUTO DR. Tempe, AZ 85284 |
Product Code | OAN |
CFR Regulation Number | 882.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-12-05 |
Decision Date | 2002-01-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DOC BAND 75174153 2153422 Live/Registered |
Cranial Technologies, Inc. 1996-09-30 |