The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Modification To: Nipro Safe Touch Safety Fistula Needle.
| Device ID | K032777 |
| 510k Number | K032777 |
| Device Name: | MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | NIPRO MEDICAL CORP. 510 STONEMONT DR. Weston, FL 33326 |
| Contact | Richard D Bliss |
| Correspondent | Richard D Bliss NIPRO MEDICAL CORP. 510 STONEMONT DR. Weston, FL 33326 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-08 |
| Decision Date | 2003-11-14 |
| Summary: | summary |