510(k) K821139
- Device
- SPS-SINGLE PATIENT SYSTEM
- Applicant
- EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
- 510(k) number
- K821139
- Product code
- FIR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-05-10
- Date received
- 1982-04-21
- Regulation
- 876.5820
- Classification name
- Pump, Blood, Extra-luminal
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES K MCCRACKEN
- Address
- Royal & Ross Rd.S King Of Prussia PA US 19406 19406
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FIR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961137 | ATI PLASMA PUMP (PP-04) | Apheresis Technologies, Inc. | 1996-06-14 |
| K831953 | INFUSION PUMP | Cryosan, Inc. | 1983-07-19 |
| K830818 | ASAHI BLOOD/PLASMA PUMP #ABP-01A & | Parker Hannifin Corp. | 1983-04-12 |
| K780410 | BLOOD PUMP-MODE S10K | 3M Health Care, Sarns | 1978-05-03 |
| K771705 | RS-7800 MINIPUMP | Renal Systems, Inc. | 1977-10-04 |
| K761050 | HEPARIN PUMP | Dws, Inc. | 1976-12-30 |
Legacy Summary#
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FDA Review#
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