The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Nutrisafe 2.
| Device ID | K060944 |
| 510k Number | K060944 |
| Device Name: | NUTRISAFE 2 |
| Classification | Tube, Feeding |
| Applicant | VYGON CORP. 2495 GENERAL ARMISTEAD AVE Norristown, PA 19403 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith VYGON CORP. 2495 GENERAL ARMISTEAD AVE Norristown, PA 19403 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-06 |
| Decision Date | 2006-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38498840000114 | K060944 | 000 |
| 30849884005180 | K060944 | 000 |
| 30849884005173 | K060944 | 000 |
| 30849884005166 | K060944 | 000 |
| 30849884002240 | K060944 | 000 |
| 30849884002233 | K060944 | 000 |
| 30849884002226 | K060944 | 000 |
| 30849884002219 | K060944 | 000 |
| 30849884002202 | K060944 | 000 |
| 30849884002394 | K060944 | 000 |
| 30849884000888 | K060944 | 000 |
| 50849884000899 | K060944 | 000 |
| 38498840000107 | K060944 | 000 |
| 38498840000091 | K060944 | 000 |
| 58498840000088 | K060944 | 000 |
| 38498840000077 | K060944 | 000 |
| 58498840000064 | K060944 | 000 |
| 50849884000936 | K060944 | 000 |
| 30849884000925 | K060944 | 000 |
| 30849884000918 | K060944 | 000 |
| 50849884000905 | K060944 | 000 |
| 28015262022246 | K060944 | 000 |