Device Classification Name |
Gauze/Sponge, Internal, X-Ray Detectable
|
510(k) Number |
K920356 |
Device Name |
SURGICAL SPONGES |
Applicant |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
P.O. BOX 326 |
NORTH STONINGTON,
CT
06359
|
|
Applicant Contact |
GEORGE P KORTEWEG |
Correspondent |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
P.O. BOX 326 |
NORTH STONINGTON,
CT
06359
|
|
Correspondent Contact |
GEORGE P KORTEWEG |
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 01/27/1992 |
Decision Date | 08/06/1992 |
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
|
|
|