Device Classification Name |
Sponge, Ophthalmic
|
510(k) Number |
K942642 |
Device Name |
SURGI-WIPE |
Applicant |
SURGIN SURGICAL INSTRUMENTATION, INC. |
14762 BENTLEY CIRCLE |
TUSTIN,
CA
92680
|
|
Applicant Contact |
DON HAAR |
Correspondent |
SURGIN SURGICAL INSTRUMENTATION, INC. |
14762 BENTLEY CIRCLE |
TUSTIN,
CA
92680
|
|
Correspondent Contact |
DON HAAR |
Regulation Number | 886.4790
|
Classification Product Code |
|
Date Received | 06/03/1994 |
Decision Date | 07/15/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|