The following data is part of a premarket notification filed by Bradstreet Clinical Research Assoc., Inc. with the FDA for Ryder Contact Lens Case.
Device ID | K951181 |
510k Number | K951181 |
Device Name: | RYDER CONTACT LENS CASE |
Classification | Case, Contact Lens |
Applicant | BRADSTREET CLINICAL RESEARCH ASSOC., INC. 1588 ROUTE 130 NORTH SUITE C-2 North Brunswick, NJ 08902 |
Contact | Patricia W Bradstreet |
Correspondent | Patricia W Bradstreet BRADSTREET CLINICAL RESEARCH ASSOC., INC. 1588 ROUTE 130 NORTH SUITE C-2 North 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 | 1995-03-16 |
Decision Date | 1995-05-12 |