The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Safetouch Psv Winged Infusion Set With/without Filter.
| Device ID | K132153 |
| 510k Number | K132153 |
| Device Name: | SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Contact | Jessica Oswald-mcleod |
| Correspondent | Jessica Oswald-mcleod NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-12 |
| Decision Date | 2013-12-05 |
| Summary: | summary |