MACRO SUCTION TUBE MODEL NO 10061

Apparatus, Suction, Single Patient Use, Portable, Nonpowered

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Macro Suction Tube Model No 10061.

Pre-market Notification Details

Device IDK950754
510k NumberK950754
Device Name:MACRO SUCTION TUBE MODEL NO 10061
ClassificationApparatus, Suction, Single Patient Use, Portable, Nonpowered
Applicant DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids,  MI  49501
ContactMarjorie Bush
CorrespondentMarjorie Bush
DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids,  MI  49501
Product CodeGCY  
CFR Regulation Number878.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-17
Decision Date1995-04-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994570486 K950754 000
20613994570462 K950754 000

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