The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Percupump Ii.
| Device ID | K932055 |
| 510k Number | K932055 |
| Device Name: | PERCUPUMP II |
| Classification | Pump, Infusion Or Syringe, Extra-luminal |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Merribeth Adams |
| Correspondent | Merribeth Adams E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | FIH |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-28 |
| Decision Date | 1995-03-21 |