Device Classification Name |
Brush, Scrub, Operating-Room
|
510(k) Number |
K830394 |
Device Name |
PROVIDONE-IODINE PREP-PADS & TOWELETTES |
Applicant |
H & P INDUSTRIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
H & P INDUSTRIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 02/07/1983 |
Decision Date | 04/06/1983 |
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
|