The following data is part of a premarket notification filed by Biocellulase, Inc. with the FDA for Smoothshapes.
Device ID | K061603 |
510k Number | K061603 |
Device Name: | SMOOTHSHAPES |
Classification | Massager, Vacuum, Light Induced Heating |
Applicant | BIOCELLULASE, INC. ONE APPLE HILL DRIVE SUITE 316 Natick, MA 01760 |
Contact | Robert Nagel |
Correspondent | Robert Nagel BIOCELLULASE, INC. ONE APPLE HILL DRIVE SUITE 316 Natick, MA 01760 |
Product Code | NUV |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-08 |
Decision Date | 2006-07-03 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SMOOTHSHAPES 76650103 3402272 Dead/Cancelled |
CYNOSURE, INC. 2005-11-10 |