510(k) K811439
- Device
- EXP 200 PARALLEL PLATE DIALYZER
- Applicant
- EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
- 510(k) number
- K811439
- Product code
- FJG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-06-12
- Date received
- 1981-05-22
- Regulation
- 876.5820
- Classification name
- Dialyzer, Parallel Flow
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FJG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933681 | GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS | Cobe Renal Care, Inc. | 1994-09-07 |
| K933680 | GAMBRO LUNDIA PRO 200 DIALYZER | Cobe Renal Care, Inc. | 1994-08-26 |
| K920693 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 | National Medical Care, Medical Products Div., Inc. | 1992-09-21 |
| K915504 | GAMBRO LUNDIA ALPHA HEMODIALYZERS | C.G.H. Medical, Inc. | 1992-03-06 |
| K901368 | HEMOSPAL KITS A1, A2D, AO, & A1D | Gambro-Hospal, Inc. | 1990-08-02 |
| K902203 | TENCKHOFF PERITONEAL DIALYSIS KIT | Akcess Medical Products, Inc. | 1990-08-01 |
| K862840 | GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N | Gambro, Inc. | 1986-09-29 |
| K853406 | GAMBRO LUNDIA PRO 3 & 5 DIALYZER | Gambro, Inc. | 1986-01-08 |
| K820694 | COBE PPD 1.3L, #18-520-009 | Cobe Laboratories, Inc. | 1982-03-31 |
| K812336 | COBE PPD 1.9 | Cobe Laboratories, Inc. | 1981-08-31 |
| K811440 | EXP 600 PARALLEL PLATE DIALYZER | Extracorporeal Medical Specialities, Inc. | 1981-06-12 |
| K810066 | COBE PPD .8 | Cobe Laboratories, Inc. | 1981-06-09 |
| K810837 | CYBER 80 HEMODIALYZER | Cyberex Corp. | 1981-05-05 |
| K802478 | CYBER 120 HEMODIALYZER | Cyberex Corp. | 1981-03-20 |
| K803068 | NIKKISO ND-14 PARALLEL FLOW DIALYZER | NIKKISO CO., LTD. | 1981-03-04 |
Legacy Summary#
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FDA Review#
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