Device Classification Name |
gauze/sponge, internal, x-ray detectable
|
510(k) Number |
K972634 |
Device Name |
ULTRACELL SUCTION SPONGE |
Applicant |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
183 PROVIDENCE, |
NEW LONDON TNPK |
NORTH STONINGTON,
CT
06359
|
|
Applicant Contact |
GEORGE P KORTEWEG |
Correspondent |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
183 PROVIDENCE, |
NEW LONDON TNPK |
NORTH STONINGTON,
CT
06359
|
|
Correspondent Contact |
GEORGE P KORTEWEG |
Regulation Number | 878.4450
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/14/1997 |
Decision Date | 12/17/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|