The following data is part of a premarket notification filed by Excelsior Medical Corp. with the FDA for Swabflsuh (3ml, 5ml, 10ml) Model 10331, 10351, 10311.
Device ID | K101270 |
510k Number | K101270 |
Device Name: | SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 |
Classification | Saline, Vascular Access Flush |
Applicant | EXCELSIOR MEDICAL CORP. 4 INNOVATION DRIVE Dundas, On, CA L2h 7p3 |
Contact | Nancy Ruth |
Correspondent | Nancy Ruth EXCELSIOR MEDICAL CORP. 4 INNOVATION DRIVE Dundas, On, CA L2h 7p3 |
Product Code | NGT |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-05-06 |
Decision Date | 2011-02-10 |
Summary: | summary |