NEO NEST


Device Classification Name

pack, hot or cold, disposable

510(k) Number K112547
Device Name NEO NEST
Applicant
DENOVO PROUCTS LLC
17051 alico commerce ct. #3
ft. myers, 
FL 
33967

Applicant Contact dale walters
Correspondent
DENOVO PROUCTS LLC
17051 alico commerce ct. #3
ft. myers, 
FL 
33967

Correspodent Contact dale walters
Regulation Number 890.5710
Classification Product Code
IMD  
Date Received 09/01/2011
Decision Date 03/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No