The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Extracorporeal Single Needle Module.
| Device ID | K822340 |
| 510k Number | K822340 |
| Device Name: | EXTRACORPOREAL SINGLE NEEDLE MODULE |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. ROYAL & ROSS ROADS King Of Prussia , PA 19406 - |
| Contact | James J Mcdcracken |
| Correspondent | James J Mcdcracken EXTRACORPOREAL MEDICAL SPECIALITIES, INC. ROYAL & ROSS ROADS King Of Prussia , PA 19406 - |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-04 |
| Decision Date | 1982-11-03 |