The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Percu-set(tm).
| Device ID | K900021 |
| 510k Number | K900021 |
| Device Name: | PERCU-SET(TM) |
| Classification | Sampler, Amniotic Fluid (amniocentesis Tray) |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Jack T Berger |
| Correspondent | Jack T Berger E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | HIO |
| CFR Regulation Number | 884.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-02 |
| Decision Date | 1990-03-29 |