RADIOGRAPHIC - LEG SECTION

Table, Cystometric, Non-electric And Accessories

AMERICAN STERILIZER CO.

The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Radiographic - Leg Section.

Pre-market Notification Details

Device IDK864846
510k NumberK864846
Device Name:RADIOGRAPHIC - LEG SECTION
ClassificationTable, Cystometric, Non-electric And Accessories
Applicant AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie,  PA  16514
ContactJames A Spallina
CorrespondentJames A Spallina
AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie,  PA  16514
Product CodeKQS  
CFR Regulation Number876.4890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-10
Decision Date1986-12-24

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