Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K884127 |
Device Name |
LAKE N/G FEEDING TUBE |
Applicant |
LAKE MEDICAL PRODUCTS, INC. |
11866 ADIE RD. |
MARYLAND HEIGHTS,
MO
63043
|
|
Applicant Contact |
ELI SCHACHET |
Correspondent |
LAKE MEDICAL PRODUCTS, INC. |
11866 ADIE RD. |
MARYLAND HEIGHTS,
MO
63043
|
|
Correspondent Contact |
ELI SCHACHET |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/30/1988 |
Decision Date | 02/08/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|