Device Classification Name |
Tray, Surgical, Needle
|
510(k) Number |
K813338 |
Device Name |
BIOPSY NEEDLES & TRAYS |
Applicant |
AMERICAN PHARMASEAL DIV. AHSC |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AMERICAN PHARMASEAL DIV. AHSC |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/24/1981 |
Decision Date | 01/28/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|