The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Protectiv Safety Blood Collection Needle.
| Device ID | K001690 |
| 510k Number | K001690 |
| Device Name: | PROTECTIV SAFETY BLOOD COLLECTION NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
| Contact | Dorene Markwiese |
| Correspondent | Dorene Markwiese JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-02 |
| Decision Date | 2000-07-31 |