PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL

Instruments, Surgical, Cardiovascular

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Phrenic Nerve Pad & Nerve Pad W/1/4 Percardial.

Pre-market Notification Details

Device IDK890707
510k NumberK890707
Device Name:PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL
ClassificationInstruments, Surgical, Cardiovascular
Applicant DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
ContactVan Hof
CorrespondentVan Hof
DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
Product CodeDWS  
CFR Regulation Number870.4500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-10
Decision Date1989-04-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20613994844884 K890707 000
20613994844877 K890707 000

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