The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Visine For Contacts.
Device ID | K991620 |
510k Number | K991620 |
Device Name: | VISINE FOR CONTACTS |
Classification | Accessories, Soft Lens Products |
Applicant | PFIZER, INC. 235 EAST 42ND ST. New York, NY 10017 |
Contact | John Tomaszewski |
Correspondent | John Tomaszewski PFIZER, INC. 235 EAST 42ND ST. New York, NY 10017 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-11 |
Decision Date | 1999-09-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00074300012537 | K991620 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VISINE FOR CONTACTS 75606651 2451584 Live/Registered |
JOHNSON & JOHNSON 1998-12-16 |