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 |