The following data is part of a premarket notification filed by California Medical Laboratories, Inc. with the FDA for California Medical Laboratories Inc. Standard And Small Rigid Tip Suction Wands.
| Device ID | K982891 |
| 510k Number | K982891 |
| Device Name: | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS |
| Classification | Sucker, Cardiotomy Return, 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 | DTS |
| CFR Regulation Number | 870.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-17 |
| Decision Date | 1998-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622105910 | K982891 | 000 |
| 10803622105811 | K982891 | 000 |
| 10803622105828 | K982891 | 000 |
| 10803622105835 | K982891 | 000 |
| 10803622105842 | K982891 | 000 |
| 10803622105859 | K982891 | 000 |
| 10803622105866 | K982891 | 000 |
| 10803622105873 | K982891 | 000 |
| 10803622105880 | K982891 | 000 |
| 10803622105897 | K982891 | 000 |
| 10803622105903 | K982891 | 000 |
| 10803622105804 | K982891 | 000 |