MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10


Device Classification Name

device, neurovascular embolization

510(k) Number K103758
Device Name MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
Applicant
MICROVENTION, INC.
1311 valencia ave
tustin, 
CA 
92780

Applicant Contact laraine pangelina
Correspondent
MICROVENTION, INC.
1311 valencia ave
tustin, 
CA 
92780

Correspodent Contact laraine pangelina
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 12/23/2010
Decision Date 04/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No