The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for Paragon Lens Carrier.
Device ID | K993486 |
510k Number | K993486 |
Device Name: | PARAGON LENS CARRIER |
Classification | Case, Contact Lens |
Applicant | PARAGON VISION SCIENCES 947 EAST IMPALA AVE. Mesa, AZ 85204 |
Contact | William E Meyers |
Correspondent | William E Meyers PARAGON VISION SCIENCES 947 EAST IMPALA AVE. Mesa, AZ 85204 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-15 |
Decision Date | 1999-12-22 |
Summary: | summary |