The following data is part of a premarket notification filed by Clinical Research Assoc. with the FDA for Ryder Contact Lens Case.
Device ID | K943921 |
510k Number | K943921 |
Device Name: | RYDER CONTACT LENS CASE |
Classification | Case, Contact Lens |
Applicant | CLINICAL RESEARCH ASSOC. 1588 ROUTE 130 NORTH SUITE C-2 Brunswick, NJ 08902 |
Contact | Patricia W Bradstreet |
Correspondent | Patricia W Bradstreet CLINICAL RESEARCH ASSOC. 1588 ROUTE 130 NORTH SUITE C-2 Brunswick, NJ 08902 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-12 |
Decision Date | 1994-10-11 |