Device Classification Name |
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
|
510(k) Number |
K944857 |
Device Name |
GOGGLE SAFEGUARD |
Applicant |
SELLSTROM MFG. CO. |
ONE SELLSTROM DR. |
PALATINE,
IL
60067
|
|
Applicant Contact |
LORI BUTLER |
Correspondent |
SELLSTROM MFG. CO. |
ONE SELLSTROM DR. |
PALATINE,
IL
60067
|
|
Correspondent Contact |
LORI BUTLER |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 09/30/1994 |
Decision Date | 12/15/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|