Device Classification Name |
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
|
510(k) Number |
K930347 |
Device Name |
SHAIDS PROTECTIVE GLASSES |
Applicant |
DEPUY, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
DAVID A KOTKOVETZ |
Correspondent |
DEPUY, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
DAVID A KOTKOVETZ |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 01/25/1993 |
Decision Date | 04/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|