PENTAMAX 1 MODEL B TABLE SYSTEM

Table, Radiographic, Tilting

SPECTRUM X-RAY CORP.

The following data is part of a premarket notification filed by Spectrum X-ray Corp. with the FDA for Pentamax 1 Model B Table System.

Pre-market Notification Details

Device IDK870707
510k NumberK870707
Device Name:PENTAMAX 1 MODEL B TABLE SYSTEM
ClassificationTable, Radiographic, Tilting
Applicant SPECTRUM X-RAY CORP. P.O. BOX 155 RYAN AVE. Westville,  NJ  08093
ContactTheresa Mcglone
CorrespondentTheresa Mcglone
SPECTRUM X-RAY CORP. P.O. BOX 155 RYAN AVE. Westville,  NJ  08093
Product CodeIXR  
CFR Regulation Number892.1980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-20
Decision Date1987-05-14

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