Device Classification Name |
sigmoidoscope and accessories, flexible/rigid
|
510(k) Number |
K822765 |
Device Name |
SIGMOIDOSCOPE, FLEXIBLE |
Applicant |
HARVARD LABORATORIES |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
HARVARD LABORATORIES |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/14/1982 |
Decision Date | 11/17/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|