The following data is part of a premarket notification filed by Advantage Medical Systems, Inc. with the FDA for Non-coring Huber Type Needles.
| Device ID | K873957 |
| 510k Number | K873957 |
| Device Name: | NON-CORING HUBER TYPE NEEDLES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ADVANTAGE MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham, PA 19044 |
| Contact | Joel A Marcus |
| Correspondent | Joel A Marcus ADVANTAGE MEDICAL SYSTEMS, INC. 905 SHEEHY DR. Horsham, PA 19044 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-28 |
| Decision Date | 1987-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38498840008721 | K873957 | 000 |
| 30849884001717 | K873957 | 000 |
| 58498840006813 | K873957 | 000 |
| 58498840006820 | K873957 | 000 |
| 58498840006837 | K873957 | 000 |
| 38498840006840 | K873957 | 000 |
| 38498840006857 | K873957 | 000 |
| 58498840006868 | K873957 | 000 |
| 58498840006882 | K873957 | 000 |
| 38498840006895 | K873957 | 000 |
| 58498840006905 | K873957 | 000 |
| 38498840006918 | K873957 | 000 |
| 58498840006929 | K873957 | 000 |
| 38498840006932 | K873957 | 000 |
| 38498840006949 | K873957 | 000 |
| 30849884001434 | K873957 | 000 |