DENOVO TEDDY GEL INFANT HEEL WARMER


Device Classification Name

infant heel warmer (chemical heat pack)

510(k) Number K103549
Device Name DENOVO TEDDY GEL INFANT HEEL WARMER
Applicant
DENOVO PRODUCTS LLC
17051 alico commerce court
unit 3
fort myers, 
FL 
33967

Applicant Contact dale walters
Correspondent
DENOVO PRODUCTS LLC
17051 alico commerce court
unit 3
fort myers, 
FL 
33967

Correspodent Contact dale walters
Regulation Number 890.5710
Classification Product Code
MPO  
Date Received 12/03/2010
Decision Date 04/08/2011
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