The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Alcon Contact Lens Case.
| Device ID | K971618 |
| 510k Number | K971618 |
| Device Name: | ALCON CONTACT LENS CASE |
| Classification | Case, Contact Lens |
| Applicant | ALCON LABORATORIES 6201 S FREEWAY Ft Worth, TX 76134 |
| Contact | Micheal E Pfleger |
| Correspondent | Micheal E Pfleger ALCON LABORATORIES 6201 S FREEWAY Ft Worth, TX 76134 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-02 |
| Decision Date | 1997-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00300650180078 | K971618 | 000 |
| 00300650180023 | K971618 | 000 |