Device Classification Name |
device, irrigation, ocular surgery
|
510(k) Number |
K820680 |
Device Name |
DISPOSABLE TUBING SETS |
Applicant |
INNOVATIVE SURGICAL PRODUCTS INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
INNOVATIVE SURGICAL PRODUCTS INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 886.4360
|
Classification Product Code |
|
Date Received | 03/11/1982 |
Decision Date | 04/09/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|