The following data is part of a premarket notification filed by Baxa Corp. with the FDA for Swabbable Cap, Model 60205.
Device ID | K070163 |
510k Number | K070163 |
Device Name: | SWABBABLE CAP, MODEL 60205 |
Classification | Administration Set Docking Station |
Applicant | BAXA CORP. 14445 GRASSLANDS DR. Englewood, CO 80112 -7062 |
Contact | Kimberly Zizik |
Correspondent | Kimberly Zizik BAXA CORP. 14445 GRASSLANDS DR. Englewood, CO 80112 -7062 |
Product Code | ODI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-17 |
Decision Date | 2007-08-03 |
Summary: | summary |