The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Safetouch Huber Infustion Set.
| Device ID | K081210 |
| 510k Number | K081210 |
| Device Name: | NIPRO SAFETOUCH HUBER INFUSTION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | NIPRO MEDICAL CORP. 3150 NW 107TH AVE. Miami, FL 33172 |
| Contact | Jessica Oswald |
| Correspondent | Jessica Oswald NIPRO MEDICAL CORP. 3150 NW 107TH AVE. Miami, FL 33172 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-29 |
| Decision Date | 2008-10-21 |
| Summary: | summary |