The following data is part of a premarket notification filed by Denovo Proucts Llc with the FDA for Neo Nest.
Device ID | K112547 |
510k Number | K112547 |
Device Name: | NEO NEST |
Classification | Pack, Hot Or Cold, Disposable |
Applicant | DENOVO PROUCTS LLC 17051 ALICO COMMERCE CT. #3 Ft. Myers, FL 33967 |
Contact | Dale Walters |
Correspondent | Dale Walters DENOVO PROUCTS LLC 17051 ALICO COMMERCE CT. #3 Ft. Myers, FL 33967 |
Product Code | IMD |
CFR Regulation Number | 890.5710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-01 |
Decision Date | 2012-03-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NEO NEST 85438499 not registered Dead/Abandoned |
DeNovo Products L.L.C. 2011-10-04 |
NEO NEST 75556318 not registered Dead/Abandoned |
Herman, Carole J. 1998-09-18 |