Device Classification Name |
Gauze/Sponge, Internal, X-Ray Detectable
|
510(k) Number |
K792630 |
Device Name |
STERILIZATION PROCESS/X-RAY DETECT. SPG |
Applicant |
PROCTER & GAMBLE MFG. CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
PROCTER & GAMBLE MFG. CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 12/19/1979 |
Decision Date | 01/11/1980 |
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
|