Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K922441 |
Device Name |
SURESEAL BANDAGE |
Applicant |
GAINOR MEDICAL EUROPE, LTD. |
310 HOLDEN SHORE |
SUTIE 240 |
LONG BEACH,
CA
90802
|
|
Applicant Contact |
GAINOR |
Correspondent |
GAINOR MEDICAL EUROPE, LTD. |
310 HOLDEN SHORE |
SUTIE 240 |
LONG BEACH,
CA
90802
|
|
Correspondent Contact |
GAINOR |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 05/22/1992 |
Decision Date | 08/10/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|