The following data is part of a premarket notification filed by Lobob Laboratories, Inc. with the FDA for Lobob Universal Contact Lens Cleaner.
Device ID | K990044 |
510k Number | K990044 |
Device Name: | LOBOB UNIVERSAL CONTACT LENS CLEANER |
Classification | Accessories, Soft Lens Products |
Applicant | LOBOB LABORATORIES, INC. 2000 M ST. NW # 700 Washington, DC 20036 -3307 |
Contact | Daniel J Manelli |
Correspondent | Daniel J Manelli LOBOB LABORATORIES, INC. 2000 M ST. NW # 700 Washington, DC 20036 -3307 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-06 |
Decision Date | 1999-02-11 |
Summary: | summary |