Search Results
Found 2 results
510(k) Data Aggregation
K Number
K974758Device Name
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
Manufacturer
HYDROX LABORATORIES
Date Cleared
1998-03-09
(80 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Applicant Name (Manufacturer) :
HYDROX LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not for injection, for suction catheter procedures. Hydrox Sterile Water is intended to be used in device lubrication, moistening and flusling. It is not intended for wound irrigation or IV or IM administration and is labeled as such.
The intended use of this device is the same as the intended use of similar devices currently in the market.
Device Description
Hydrox Sterile Water 4 oz. Cup 120 ml, Trade Name: Hvdrox Sterile Water 100 ml Bottle
Ask a Question
K Number
K974759Device Name
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
Manufacturer
HYDROX LABORATORIES
Date Cleared
1998-03-09
(80 days)
Product Code
JOL
Regulation Number
880.6740Why did this record match?
Applicant Name (Manufacturer) :
HYDROX LABORATORIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not for injection, for suction catheter procedures. Hydrox Sterile Saline 0.9% Sodium Chloride Solution is intended to be used in device lubrication, moistening and flushing. It is not intended for wound irrigation or IV or IM administration and is labeled as such.
Device Description
Sterile Saline 0.9% Sodium Chloride Solution
Ask a Question
Page 1 of 1