The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Pallikaris Brush.
Device ID | K960261 |
510k Number | K960261 |
Device Name: | PALLIKARIS BRUSH |
Classification | Burr, Corneal, Battery-powered |
Applicant | ALCON LABORATORIES, INC. 520 N. SEMORAN BLVD. SUITE 180 Orlando, FL 32807 |
Contact | S. K Mcgarvey |
Correspondent | S. K Mcgarvey ALCON LABORATORIES, INC. 520 N. SEMORAN BLVD. SUITE 180 Orlando, FL 32807 |
Product Code | HOG |
CFR Regulation Number | 886.4070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-18 |
Decision Date | 1996-03-11 |