Device Classification Name |
Insufflator, Automatic Carbon-Dioxide For Endoscope
|
510(k) Number |
K844689 |
Device Name |
ENDOSCOPIC MANUAL AIR INSUFFLATOR |
Applicant |
JAYCO PHARMACEUTICALS |
895 POPLAR CHURCH RD. |
CAMP HILL,
PA
17011
|
|
Applicant Contact |
LESTER J LIFTON |
Correspondent |
JAYCO PHARMACEUTICALS |
895 POPLAR CHURCH RD. |
CAMP HILL,
PA
17011
|
|
Correspondent Contact |
LESTER J LIFTON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/03/1984 |
Decision Date | 01/02/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|