MATTRESS COVER

Garment, Protective, For Incontinence

INTERA CORP.

The following data is part of a premarket notification filed by Intera Corp. with the FDA for Mattress Cover.

Pre-market Notification Details

Device IDK862380
510k NumberK862380
Device Name:MATTRESS COVER
ClassificationGarment, Protective, For Incontinence
Applicant INTERA CORP. P.O. BOX 25376 Chattanooga,  TN  37422 -5376
ContactBruce Lindquist
CorrespondentBruce Lindquist
INTERA CORP. P.O. BOX 25376 Chattanooga,  TN  37422 -5376
Product CodeEYQ  
CFR Regulation Number876.5920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-24
Decision Date1986-07-28

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