The following data is part of a premarket notification filed by Pharmaseal Div., Baxter Healthcare Corp. with the FDA for Ammocentesis Tray (kit).
| Device ID | K761230 |
| 510k Number | K761230 |
| Device Name: | AMMOCENTESIS TRAY (KIT) |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | PHARMASEAL DIV., BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-12-10 |
| Decision Date | 1976-12-17 |