The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Quick Sampler Holder.
Device ID | K120490 |
510k Number | K120490 |
Device Name: | QUICK SAMPLER HOLDER |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
Contact | Jessica Oswald |
Correspondent | Jessica Oswald NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-17 |
Decision Date | 2012-12-27 |
Summary: | summary |