Device Classification Name |
Pump, Infusion Or Syringe, Extra-Luminal
|
510(k) Number |
K900439 |
Device Name |
SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC |
Applicant |
L H M ENT., INC. |
237 DINGLETOWN RD. |
INDIAN MILLS,
NJ
08088
|
|
Applicant Contact |
PATRICK J LAMB |
Correspondent |
L H M ENT., INC. |
237 DINGLETOWN RD. |
INDIAN MILLS,
NJ
08088
|
|
Correspondent Contact |
PATRICK J LAMB |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 01/29/1990 |
Decision Date | 02/15/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|