MEDIA CULTURE SYSTEM

Media, Reproductive

INTL., INC.

The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Media Culture System.

Pre-market Notification Details

Device IDK040530
510k NumberK040530
Device Name:MEDIA CULTURE SYSTEM
ClassificationMedia, Reproductive
Applicant INTL., INC. 393 SOUNDVIEW RD. Guilford,  CT  06443
ContactMichael D Cecchi
CorrespondentMichael D Cecchi
INTL., INC. 393 SOUNDVIEW RD. Guilford,  CT  06443
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-01
Decision Date2004-06-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815965020235 K040530 000
00815965020099 K040530 000
00815965020105 K040530 000
00815965020112 K040530 000
00815965020129 K040530 000
00815965020136 K040530 000
00815965020143 K040530 000
00815965020150 K040530 000
00815965020167 K040530 000
00815965020204 K040530 000
00815965020211 K040530 000
00815965020228 K040530 000
00815965020082 K040530 000

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