Device Classification Name |
anoscope and accessories
|
510(k) Number |
K020702 |
Device Name |
O'REGAN DISPOSABLE ANOSCOPE |
Applicant |
CANADIAN THEATRE PRODUCTS LTD. |
#210-828 HARBOUSIDE DR. |
NORTH VANCOUVER, B.C.,
CA
V7P 3R9
|
|
Applicant Contact |
ANN-MARIE O'KEEFE |
Correspondent |
CANADIAN THEATRE PRODUCTS LTD. |
#210-828 HARBOUSIDE DR. |
NORTH VANCOUVER, B.C.,
CA
V7P 3R9
|
|
Correspondent Contact |
ANN-MARIE O'KEEFE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/04/2002 |
Decision Date | 03/29/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|