DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B

Clamp, Umbilical

DYNAREX CORP.

The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Dynarex Umbilical Cord Lamp, Models 6833 And 6833-b.

Pre-market Notification Details

Device IDK012917
510k NumberK012917
Device Name:DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
ClassificationClamp, Umbilical
Applicant DYNAREX CORP. 7736 WOODSIDE COURT Maineville,  OH  45039
ContactJohn Gagliardi
CorrespondentJohn Gagliardi
DYNAREX CORP. 7736 WOODSIDE COURT Maineville,  OH  45039
Product CodeHFW  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-30
Decision Date2001-11-28
Summary:summary

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