HEPARIN CONTROL PLASMA LEVEL 1


Device Classification Name

plasma, coagulation control

510(k) Number K992278
Device Name HEPARIN CONTROL PLASMA LEVEL 1
Applicant
PACIFIC HEMOSTASIS
11515 vanstory dr.
huntersville, 
NC 
28078 -8144

Applicant Contact laura a worfolk
Correspondent
PACIFIC HEMOSTASIS
11515 vanstory dr.
huntersville, 
NC 
28078 -8144

Correspodent Contact laura a worfolk
Regulation Number 864.5425
Classification Product Code
GGN  
Date Received 07/07/1999
Decision Date 08/26/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized