The following data is part of a premarket notification filed by Eye Care And Cure with the FDA for Eye Care Cure Contact Lens Case.
Device ID | K112832 |
510k Number | K112832 |
Device Name: | EYE CARE CURE CONTACT LENS CASE |
Classification | Case, Contact Lens |
Applicant | EYE CARE AND CURE 4646 S OVERLAND DR Tucson, AZ 85714 |
Contact | Lindy V Dalen |
Correspondent | Lindy V Dalen EYE CARE AND CURE 4646 S OVERLAND DR Tucson, AZ 85714 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-29 |
Decision Date | 2011-12-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00360843006233 | K112832 | 000 |
00360843002938 | K112832 | 000 |
00360843002921 | K112832 | 000 |
00360843001405 | K112832 | 000 |
00360843001399 | K112832 | 000 |
00360843001276 | K112832 | 000 |
00360843008961 | K112832 | 000 |