The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Rgp Multi-purpose Solution Id 100136.
Device ID | K000148 |
510k Number | K000148 |
Device Name: | RGP MULTI-PURPOSE SOLUTION ID 100136 |
Classification | Products, Contact Lens Care, Rigid Gas Permeable |
Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
Contact | Ralph H Larsen |
Correspondent | Ralph H Larsen ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
Product Code | MRC |
CFR Regulation Number | 886.5918 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-18 |
Decision Date | 2000-04-11 |