The following data is part of a premarket notification filed by Uc-care Medical Systems Ltd with the FDA for Uc-care Positioning System.
| Device ID | K082919 |
| 510k Number | K082919 |
| Device Name: | UC-CARE POSITIONING SYSTEM |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | UC-CARE MEDICAL SYSTEMS LTD 555 13TH ST., NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan UC-CARE MEDICAL SYSTEMS LTD 555 13TH ST., NW Washington, DC 20004 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2008-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016936247 | K082919 | 000 |