510(k) Premarket Notification Database
Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number | K984098 |
Regulation Number |
886.5925
|
Device Name | ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS |
Applicant |
ADVENTURES IN COLOR TECHNOLOGY, LTD.
|
623 glacier dr. |
grand junction,
CO
81503 |
|
Contact | martin dalsing |
Product Code | LPL |
Date Received | 11/17/1998 |
Decision Date | 05/10/1999 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Ophthalmic
|
Review Advisory Committee |
Ophthalmic
|
Statement/Summary/Purged Status |
Summary only
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
|
|