Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K003136 |
Device Name |
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS |
Applicant |
OCULAR SCIENCES PUERTO RICO, INC. |
12300 TWINBROOK PKWY. |
SUITE 625 |
ROCKVILLE,
MD
20852
|
|
Applicant Contact |
RICHARD E LIPPMAN |
Correspondent |
OCULAR SCIENCES PUERTO RICO, INC. |
12300 TWINBROOK PKWY. |
SUITE 625 |
ROCKVILLE,
MD
20852
|
|
Correspondent Contact |
RICHARD E LIPPMAN |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 10/06/2000 |
Decision Date | 01/06/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|