Device Classification Name |
Forceps, Ophthalmic
|
510(k) Number |
K881049 |
Device Name |
BRADBURY INTRAOCULAR RETINAL KIT CAT #200 |
Applicant |
MICROLINE PENTAX, INC. |
199 NEWBURY ST. |
DEVERS,
MA
01923
|
|
Applicant Contact |
DE LAFORCADE |
Correspondent |
MICROLINE PENTAX, INC. |
199 NEWBURY ST. |
DEVERS,
MA
01923
|
|
Correspondent Contact |
DE LAFORCADE |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 03/11/1988 |
Decision Date | 09/12/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|