The following data is part of a premarket notification filed by Paragon Vision Sciences with the FDA for Sportsight Gp.
Device ID | K993586 |
510k Number | K993586 |
Device Name: | SPORTSIGHT GP |
Classification | Lens, Contact (other Material) - Daily |
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 | HQD |
CFR Regulation Number | 886.5916 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-22 |
Decision Date | 2000-05-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B22215 | K993586 | 000 |