Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K904445 |
Device Name |
OMIBAND |
Applicant |
OMIKRON SCIENTIFIC, LTD. |
P.O. BOX 2012, KIRYAT |
WEIZMANN |
REHOVOT-76120,
IL
|
|
Applicant Contact |
MARC COLES |
Correspondent |
OMIKRON SCIENTIFIC, LTD. |
P.O. BOX 2012, KIRYAT |
WEIZMANN |
REHOVOT-76120,
IL
|
|
Correspondent Contact |
MARC COLES |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 09/28/1990 |
Decision Date | 03/06/1991 |
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
|
|
|