THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602


Device Classification Name

port & catheter, implanted, subcutaneous, intravascular

510(k) Number K960350
Device Name THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602
Applicant
BIOCONTROL TECHNOLOGY, INC.
300 indian springs rd.
p.o. box 434
indiana, 
PA 
15701

Applicant Contact patrick j cooper
Correspondent
BIOCONTROL TECHNOLOGY, INC.
300 indian springs rd.
p.o. box 434
indiana, 
PA 
15701

Correspodent Contact patrick j cooper
Regulation Number 880.5965
Classification Product Code
LJT  
Date Received 01/25/1996
Decision Date 04/15/1996
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