SPIRUS MEDICAL SURGICAL INSTRUMENT


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

Correspodent Contact pamela papineau
Regulation Number 880.6375
Classification Product Code
KMJ  
Date Received 01/08/2008
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