DYNACOR LUBRICATION GEL


Device Classification Name

lubricant, patient

510(k) Number K103718
Device Name DYNACOR LUBRICATION GEL
Applicant
MEDLINE INDUSTRIES, INC.
one medline place
mundelein, 
IL 
60060

Applicant Contact matt clausen
Correspondent
MEDLINE INDUSTRIES, INC.
one medline place
mundelein, 
IL 
60060

Correspodent Contact matt clausen
Regulation Number 880.6375
Classification Product Code
KMJ  
Date Received 12/21/2010
Decision Date 05/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No