Device Classification Name |
Syringe, Piston
|
510(k) Number |
K960248 |
Device Name |
GENERAL PROCEDURE KIT |
Applicant |
PHYSICIAN INDUSTRIES, INC. |
101 NORTH 700 WST |
P.O. BOX 540793 |
NORTH SALT LAKE,
UT
84054 -0793
|
|
Applicant Contact |
BRIAN BAKER |
Correspondent |
PHYSICIAN INDUSTRIES, INC. |
101 NORTH 700 WST |
P.O. BOX 540793 |
NORTH SALT LAKE,
UT
84054 -0793
|
|
Correspondent Contact |
BRIAN BAKER |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 01/16/1996 |
Decision Date | 04/12/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|