SPIRUS MEDICAL SURGICAL INSTRUMENT

Lubricant, Patient

SPIRUS MEDICAL, INC.

The following data is part of a premarket notification filed by Spirus Medical, Inc. with the FDA for Spirus Medical Surgical Instrument.

Pre-market Notification Details

Device IDK080042
510k NumberK080042
Device Name:SPIRUS MEDICAL SURGICAL INSTRUMENT
ClassificationLubricant, Patient
Applicant SPIRUS MEDICAL, INC. 5 WHITCOMB AVENUE Ayer,  MA  01432
ContactPamela Papineau
CorrespondentPamela Papineau
SPIRUS MEDICAL, INC. 5 WHITCOMB AVENUE Ayer,  MA  01432
Product CodeKMJ  
CFR Regulation Number880.6375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-08
Decision Date2008-04-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00867630000233 K080042 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.