Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
510(k) Number |
K862569 |
Device Name |
HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS) |
Applicant |
JEDMED INSTRUMENT CO. |
1430 HANLEY INDUSTRIAL CT. |
ST. LOUIS,
MO
63144
|
|
Applicant Contact |
CRAIG RAPP |
Correspondent |
JEDMED INSTRUMENT CO. |
1430 HANLEY INDUSTRIAL CT. |
ST. LOUIS,
MO
63144
|
|
Correspondent Contact |
CRAIG RAPP |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 07/07/1986 |
Decision Date | 08/14/1986 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|