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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Patient
510(k) Number K080042
Device Name SPIRUS MEDICAL SURGICAL INSTRUMENT
Applicant
SPIRUS MEDICAL, INC.
5 WHITCOMB AVENUE
AYER,  MA  01432
Applicant Contact PAMELA PAPINEAU
Correspondent
SPIRUS MEDICAL, INC.
5 WHITCOMB AVENUE
AYER,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received01/08/2008
Decision Date 04/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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