The following data is part of a premarket notification filed by Ryder Intl. Corp. with the FDA for Kestrel Contact Lens Storage Case(polystyrene).
Device ID | K853729 |
510k Number | K853729 |
Device Name: | KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) |
Classification | Lens, Contact (polymethylmethacrylate) |
Applicant | RYDER INTL. CORP. 100 CURT FRANCIS RD. POST OFFICE BOX 564 Arab, AL 35016 |
Contact | Anthony J Moravec |
Correspondent | Anthony J Moravec RYDER INTL. CORP. 100 CURT FRANCIS RD. POST OFFICE BOX 564 Arab, AL 35016 |
Product Code | HPX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-06 |
Decision Date | 1985-12-13 |