The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Umi Amniocentesis Kit W/spinal Needle.
| Device ID | K844558 |
| 510k Number | K844558 |
| Device Name: | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Contact | Charles M Copperber |
| Correspondent | Charles M Copperber UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Product Code | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-21 |
| Decision Date | 1985-01-31 |