Device Classification Name |
subsystem, water purification |
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---|---|---|---|---|
510(k) Number | K991916 | |||
Device Name | VIRGINIA WATER SYSTEMS’ WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | |||
Applicant |
|
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Applicant Contact | william g garrahan | |||
Correspondent |
|
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Correspodent Contact | william g garrahan | |||
Regulation Number | 876.5665 | |||
Classification Product Code |
|
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Date Received | 06/07/1999 | |||
Decision Date | 01/14/2000 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Gastroenterology/Urology |
|||
510k Review Panel |
Gastroenterology/Urology |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |