Device Classification Name |
Barrier, Std, Oral Sex
|
510(k) Number |
K970577 |
Device Name |
GLYDE DAM LOLLYES |
Applicant |
GLYDE USA, INC. |
14808 N.E. 66TH ST. |
REMOND,
WA
98052 -4712
|
|
Applicant Contact |
LOUISE C MYERS |
Correspondent |
GLYDE USA, INC. |
14808 N.E. 66TH ST. |
REMOND,
WA
98052 -4712
|
|
Correspondent Contact |
LOUISE C MYERS |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/14/1997 |
Decision Date | 01/08/1998 |
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
|
|
|