The following data is part of a premarket notification filed by Watchdog Group, Lc with the FDA for Standard Contact Lens Case; Flip N Slide Contact Lens Case.
Device ID | K130753 |
510k Number | K130753 |
Device Name: | STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE |
Classification | Case, Contact Lens |
Applicant | WATCHDOG GROUP, LC 7800 Forsyth Blvd. 8th Floor Clayton, MO 63105 |
Contact | John O'hara |
Correspondent | John O'hara WATCHDOG GROUP, LC 7800 Forsyth Blvd. 8th Floor Clayton, MO 63105 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-19 |
Decision Date | 2013-06-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10311917192588 | K130753 | 000 |
00681131057462 | K130753 | 000 |
10897522001588 | K130753 | 000 |
00078742019215 | K130753 | 000 |
00078742019192 | K130753 | 000 |