The following data is part of a premarket notification filed by Confluent Surgical,inc with the FDA for Confluent Surgical Dual Liquid Applicator, Model 70-2005093.
Device ID | K042588 |
510k Number | K042588 |
Device Name: | CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 |
Classification | Syringe, Piston |
Applicant | CONFLUENT SURGICAL,INC 101A FIRST AVE. Waltham, MA 02451 |
Contact | Eric Ankerud |
Correspondent | Eric Ankerud CONFLUENT SURGICAL,INC 101A FIRST AVE. Waltham, MA 02451 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-22 |
Decision Date | 2004-12-09 |
Summary: | summary |