The following data is part of a premarket notification filed by Applied Laboratories, Inc. with the FDA for Kestrel Contact Lens Case.
Device ID | K871714 |
510k Number | K871714 |
Device Name: | KESTREL CONTACT LENS CASE |
Classification | Accessories, Soft Lens Products |
Applicant | APPLIED LABORATORIES, INC. 3360 COMMERCE PARK DR. Columbus, IN 47201 |
Contact | Anthony J Moravec |
Correspondent | Anthony J Moravec APPLIED LABORATORIES, INC. 3360 COMMERCE PARK DR. Columbus, IN 47201 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-04 |
Decision Date | 1987-05-26 |