STERILE PHYSIOLOGICAL SALINE/STERILE WATER

Catheter And Tip, Suction

MEDCARE CUSTOM PACKAGING, INC.

The following data is part of a premarket notification filed by Medcare Custom Packaging, Inc. with the FDA for Sterile Physiological Saline/sterile Water.

Pre-market Notification Details

Device IDK943661
510k NumberK943661
Device Name:STERILE PHYSIOLOGICAL SALINE/STERILE WATER
ClassificationCatheter And Tip, Suction
Applicant MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey,  NH  03469 -0069
ContactWilliam A Hays
CorrespondentWilliam A Hays
MEDCARE CUSTOM PACKAGING, INC. WINCHESTER ST. West Swanzey,  NH  03469 -0069
Product CodeJOL  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-28
Decision Date1995-04-10

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