Device Classification Name |
Garment, Protective, For Incontinence
|
510(k) Number |
K862380 |
Device Name |
MATTRESS COVER |
Applicant |
INTERA CORP. |
P.O. BOX 25376 |
CHATTANOOGA,
TN
37422 -5376
|
|
Applicant Contact |
BRUCE LINDQUIST |
Correspondent |
INTERA CORP. |
P.O. BOX 25376 |
CHATTANOOGA,
TN
37422 -5376
|
|
Correspondent Contact |
BRUCE LINDQUIST |
Regulation Number | 876.5920
|
Classification Product Code |
|
Date Received | 06/24/1986 |
Decision Date | 07/28/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|