The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Imbibe Aspirating Xia Taps.
Device ID | K143546 |
510k Number | K143546 |
Device Name: | Imbibe Aspirating XIA Taps |
Classification | Instrument, Biopsy |
Applicant | Stryker Corporation 2 Pearl Court Allendale, NJ 07401 |
Contact | Soraya King |
Correspondent | Soraya King Stryker Corporation 2 Pearl Court Allendale, NJ 07401 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-15 |
Decision Date | 2015-03-19 |
Summary: | summary |