DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
FDA 510(k) clearance K072921 · decided 2007-11-26
Clearance details
- K-number
- K072921
- Device name
- DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
- Applicant
- Symbios Medical Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2007-10-15
- Decision date
- 2007-11-26
- Days to decision
- 42 days
- Clearance type
- Special
- Product code
- MEB
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GO recall (Z-0940-2013) | Symbios Medical Products, LLC | 2013-03-13 |