Device Classification Name |
Forceps, Ophthalmic
|
510(k) Number |
K861057 |
Device Name |
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS |
Applicant |
PRECISION-COSMET CO., INC. |
11140 BREN RD. W. |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
ROBERT L ULLEN |
Correspondent |
PRECISION-COSMET CO., INC. |
11140 BREN RD. W. |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
ROBERT L ULLEN |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 03/19/1986 |
Decision Date | 04/24/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|