AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)


Device Classification Name

neurosurgical paddie

510(k) Number K112598
Device Name AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
Applicant
AMERICAN SURGICAL COMPANY, LLC
82 sanderson avenue
lynn, 
MA 
01902

Applicant Contact michael alouane
Correspondent
AMERICAN SURGICAL COMPANY, LLC
82 sanderson avenue
lynn, 
MA 
01902

Correspodent Contact michael alouane
Regulation Number 882.4700
Classification Product Code
HBA  
Date Received 09/07/2011
Decision Date 06/20/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No