The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Blood Collecting Needle And Holders.
| Device ID | K880892 |
| 510k Number | K880892 |
| Device Name: | BLOOD COLLECTING NEEDLE AND HOLDERS |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ABCO DEALERS, INC. 6601 W. MILL RD. P.O. BOX 23090 Milwaukee, WI 53218 -1238 |
| Contact | Molly Petr |
| Correspondent | Molly Petr ABCO DEALERS, INC. 6601 W. MILL RD. P.O. BOX 23090 Milwaukee, WI 53218 -1238 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-02 |
| Decision Date | 1988-04-21 |