510(k) K932055
- Device
- PERCUPUMP II
- Applicant
- E-Z-EM, INC.
- 510(k) number
- K932055
- Product code
- FIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-21
- Date received
- 1993-04-28
- Regulation
- 876.5820
- Classification name
- Pump, Infusion Or Syringe, Extra-luminal
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MERRIBETH ADAMS
- Address
- 717 Main St. Westbury NY US 11590 11590
FDA Registration Numbers#
- 3004753774
- 3012044688
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931113 | CADD-TPN(TM) AMBULATORY INFUSION SYSTEM | Pharmacia Deltec, Inc. | 1994-04-28 |
| K935461 | VECTOR AMBULATORY DRUG DELIVERY SYSTEM | Infusion Technology Intl. | 1994-04-28 |
| K900439 | SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC | L H M Ent., Inc. | 1990-02-15 |
| K881707 | INTROCULAR FLUID INJECTOR | B&B Medical Assoc., Inc. | 1988-10-21 |
Legacy Summary#
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FDA Review#
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