The following data is part of a premarket notification filed by Delta Med Srl with the FDA for Neo Delta Self Safe T, Neo Delta Self Safe T, Neo Delta Self Safe 1, Neo Delta Self Safe 1.
| Device ID | K121007 |
| 510k Number | K121007 |
| Device Name: | NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | DELTA MED SRL 721 KRISTIN COURT Westmont, IL 60559 |
| Contact | Harry Bontrager |
| Correspondent | Harry Bontrager DELTA MED SRL 721 KRISTIN COURT Westmont, IL 60559 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-03 |
| Decision Date | 2012-12-28 |
| Summary: | summary |