Device Classification Name |
Cystotome
|
510(k) Number |
K873163 |
Device Name |
VAN DELLEN IRRIGATING CYSTOTOME |
Applicant |
VAN DELLEN, LTD. |
3810 E. 44TH ST., SUITE 301 |
P.O. BOX 27748 |
TUCSON,
AZ
85726
|
|
Applicant Contact |
ROGER DANHOF |
Correspondent |
VAN DELLEN, LTD. |
3810 E. 44TH ST., SUITE 301 |
P.O. BOX 27748 |
TUCSON,
AZ
85726
|
|
Correspondent Contact |
ROGER DANHOF |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 08/11/1987 |
Decision Date | 09/04/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|