The following data is part of a premarket notification filed by Ryder Intl. Corp. with the FDA for Kestrel Contact Lens Storage Case(polysulfone).
Device ID | K853727 |
510k Number | K853727 |
Device Name: | KESTREL CONTACT LENS STORAGE CASE(POLYSULFONE) |
Classification | Case, Contact Lens |
Applicant | RYDER INTL. CORP. 100 CURT FRANCIS RD. POST OFFICE BOX 564 Arab, AL 35016 |
Contact | Anthony Moravec |
Correspondent | Anthony Moravec RYDER INTL. CORP. 100 CURT FRANCIS RD. POST OFFICE BOX 564 Arab, AL 35016 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-06 |
Decision Date | 1986-02-07 |