The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets And Safety-lok Blood Collection, Safety Blood Colle.
| Device ID | K991088 |
| 510k Number | K991088 |
| Device Name: | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Contact | Andrea Hroncich |
| Correspondent | Andrea Hroncich BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903686532 | K991088 | 000 |
| 50382903648806 | K991088 | 000 |
| 50382903649025 | K991088 | 000 |
| 50382903672818 | K991088 | 000 |
| 50382903672832 | K991088 | 000 |
| 50382903672856 | K991088 | 000 |
| 50382903672870 | K991088 | 000 |
| 50382903672900 | K991088 | 000 |
| 50382903672924 | K991088 | 000 |
| 50382903672948 | K991088 | 000 |
| 50382903686525 | K991088 | 000 |
| 00382903672813 | K991088 | 000 |