Device Classification Name |
Knife, Ophthalmic
|
510(k) Number |
K860305 |
Device Name |
BEAVER MICRO-GEM GAUGE BLOCK |
Applicant |
RUDOLPH BEAVER, INC. |
411 WAVERLEY OAKS RD. |
P.O. BOX 9097 |
WALTHAM,
MA
02154
|
|
Applicant Contact |
ROBERT P ZOLETTI |
Correspondent |
RUDOLPH BEAVER, INC. |
411 WAVERLEY OAKS RD. |
P.O. BOX 9097 |
WALTHAM,
MA
02154
|
|
Correspondent Contact |
ROBERT P ZOLETTI |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 01/28/1986 |
Decision Date | 02/12/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|