The following data is part of a premarket notification filed by Nipro Medical Corp. with the FDA for Nipro Safetouch Ii Gamma.
| Device ID | K063721 |
| 510k Number | K063721 |
| Device Name: | NIPRO SAFETOUCH II GAMMA |
| Classification | Needle, Fistula |
| Applicant | NIPRO MEDICAL CORP. 3150 NW 107 AVE.. Miami, FL 33172 |
| Contact | Jessica Oswald |
| Correspondent | Jessica Oswald NIPRO MEDICAL CORP. 3150 NW 107 AVE.. Miami, FL 33172 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-15 |
| Decision Date | 2007-01-12 |
| Summary: | summary |