Device Classification Name |
Gauze/Sponge, Internal, X-Ray Detectable
|
510(k) Number |
K940763 |
Device Name |
ISOLYSER (8X4 12 PLY X-RAY DETECTABLE) |
Applicant |
THANTEX SPECIALTIES, INC. |
4320 INTERNATIONAL BLVD, NW |
NORCROSS,
GA
30093
|
|
Applicant Contact |
TRAVIS HONEYCUTT |
Correspondent |
THANTEX SPECIALTIES, INC. |
4320 INTERNATIONAL BLVD, NW |
NORCROSS,
GA
30093
|
|
Correspondent Contact |
TRAVIS HONEYCUTT |
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 02/18/1994 |
Decision Date | 05/02/1994 |
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
|
|
|