Device Classification Name |
lubricant, personal
|
510(k) Number |
K150147 |
Device Name |
Lubrigyn cream |
Applicant |
UNIDERM FARMACEUTICI SRL |
VIALE ENRICO ORTOLANI 211 |
ROMA,
IT
00125
|
|
Applicant Contact |
Giorgio Chiozza |
Correspondent |
ISEMED srl |
Via A. Altobelli Bonetti 3/A |
Imola,
IT
40026
|
|
Correspondent Contact |
Maurizio Pantaleoni |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 01/22/2015 |
Decision Date | 02/19/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|