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 |