| Device Classification Name |
dialyzer, capillary, hollow fiber |
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|---|---|---|---|---|
| 510(k) Number | K991908 | |||
| Device Name | IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS | |||
| Applicant |
|
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| Applicant Contact | leon lachman | |||
| Correspondent |
|
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| Correspodent Contact | leon lachman | |||
| Regulation Number | 876.5820 | |||
| Classification Product Code |
|
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| Date Received | 06/07/1999 | |||
| Decision Date | 04/17/2000 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Gastroenterology/Urology |
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| 510k Review Panel |
Gastroenterology/Urology |
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| summary |
summary |
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| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |