The following data is part of a premarket notification filed by Critical Specialties, Inc. with the FDA for Ultrasound Procedure Tray Amnicentesis Tray.
| Device ID | K890463 |
| 510k Number | K890463 |
| Device Name: | ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | CRITICAL SPECIALTIES, INC. 325 WESTTOWN RD. West Chester, PA 19382 |
| Contact | Arthur K Ferrell |
| Correspondent | Arthur K Ferrell CRITICAL SPECIALTIES, INC. 325 WESTTOWN RD. West Chester, PA 19382 |
| Product Code | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-30 |
| Decision Date | 1989-04-07 |