The following data is part of a premarket notification filed by California Medical Laboratories, Inc. with the FDA for Cannulation Tourniquet Set, 2 Tube Or 5 Tube.
| Device ID | K000830 |
| 510k Number | K000830 |
| Device Name: | CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CALIFORNIA MEDICAL LABORATORIES, INC. 2681 KELVIN AVE. Irvine, CA 92614 |
| Contact | Mehmet Bicakci |
| Correspondent | Mehmet Bicakci CALIFORNIA MEDICAL LABORATORIES, INC. 2681 KELVIN AVE. Irvine, CA 92614 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-14 |
| Decision Date | 2000-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622106917 | K000830 | 000 |
| 10803622106092 | K000830 | 000 |
| 10803622106108 | K000830 | 000 |
| 10803622106115 | K000830 | 000 |
| 10803622106122 | K000830 | 000 |
| 10803622106139 | K000830 | 000 |
| 10803622106146 | K000830 | 000 |
| 10803622106153 | K000830 | 000 |
| 10803622106160 | K000830 | 000 |
| 10803622106191 | K000830 | 000 |
| 10803622106207 | K000830 | 000 |
| 10803622106214 | K000830 | 000 |
| 10803622106887 | K000830 | 000 |
| 10803622106894 | K000830 | 000 |
| 10803622106900 | K000830 | 000 |
| 10803622106085 | K000830 | 000 |