Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K171404 |
Device Name |
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) |
Applicant |
BAUSCH + LOMB Incorporated |
1400 North Goodman Street |
Rochester NY,
NY
14609
|
|
Applicant Contact |
Glenn A. Davies |
Correspondent |
Foresight Regulatory Strategies, Inc |
187 Ballardvale Street, Suite A250 |
Wilmington,
MA
01887
|
|
Correspondent Contact |
Ellen M. Beucler |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 05/12/2017 |
Decision Date | 07/17/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|