The following data is part of a premarket notification filed by Distronic Sterile Products, Inc. with the FDA for 60 Micro Volume Extension Set W/.22 Micron Filter, 21 Extension Set W/1.2 Mivton Gilyrt, Inj. Site, Clamp.
| Device ID | K952663 |
| 510k Number | K952663 |
| Device Name: | 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP |
| Classification | Tubing, Fluid Delivery |
| Applicant | DISTRONIC STERILE PRODUCTS, INC. 124 HERITAGE AVE. Portsmouth, NH 03801 -5645 |
| Contact | Joyce Mvfouhsl |
| Correspondent | Joyce Mvfouhsl DISTRONIC STERILE PRODUCTS, INC. 124 HERITAGE AVE. Portsmouth, NH 03801 -5645 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-12 |
| Decision Date | 1995-07-14 |