The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Liquid Enzyme Id 90133.
Device ID | K981561 |
510k Number | K981561 |
Device Name: | LIQUID ENZYME ID 90133 |
Classification | Accessories, Soft Lens Products |
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 | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-01 |
Decision Date | 1998-07-24 |
Summary: | summary |