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510(k) Data Aggregation
K Number
K980909Device Name
VICHY SHOWER
Manufacturer
Date Cleared
1998-08-11
(154 days)
Product Code
Regulation Number
890.5100Why did this record match?
Applicant Name (Manufacturer) :
BOUVIER HYDRO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Vichy Shower is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.
Device Description
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K Number
K980920Device Name
EQUINOXE
Manufacturer
Date Cleared
1998-07-16
(128 days)
Product Code
Regulation Number
890.5100Why did this record match?
Applicant Name (Manufacturer) :
BOUVIER HYDRO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Relieve pain and itching, as an aid in the healing process of inflamed and traumatized tissue, and serve as a settting for removal of contamined tissue.
Device Description
Not Found
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