Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K180923 |
Device Name |
Personal Lubricating Jelly |
Applicant |
Perrigo New York, Inc. |
1700 Bathgate Ave. |
Bronx,
NY
10457 -7512
|
|
Applicant Contact |
Karen Dombrowski |
Correspondent |
Phil Triolo and Associates LC |
86 Skycrest Land |
Salt Lake City,
UT
84108
|
|
Correspondent Contact |
Phil Triolo |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 04/09/2018 |
Decision Date | 07/09/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|