The following data is part of a premarket notification filed by Viopti Ltd with the FDA for Polaroid Contactspod.
Device ID | K131783 |
510k Number | K131783 |
Device Name: | POLAROID CONTACTSPOD |
Classification | Case, Contact Lens |
Applicant | VIOPTI LTD POLAROID BLDG, VALE OF LEVEN INDUSTRIAL ESTATE Dumbarton, GB G82 3pw |
Contact | Edwin Lindsay |
Correspondent | Edwin Lindsay VIOPTI LTD POLAROID BLDG, VALE OF LEVEN INDUSTRIAL ESTATE Dumbarton, GB G82 3pw |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-17 |
Decision Date | 2014-02-21 |
Summary: | summary |