The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Small Volume Syringe.
Device ID | K062865 |
510k Number | K062865 |
Device Name: | SMALL VOLUME SYRINGE |
Classification | Syringe, Piston |
Applicant | ALCON LABORATORIES 6201 S FREEWAY Ft Worth, TX 76134 |
Contact | Sean P Griffin |
Correspondent | Sean P Griffin ALCON LABORATORIES 6201 S FREEWAY Ft Worth, TX 76134 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-25 |
Decision Date | 2007-08-23 |
Summary: | summary |