Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K923662 |
Device Name |
INGROWN TOENAIL PAD |
Applicant |
MANY BEE CO. |
43 WEST ROSE LN. |
PHOENIX,
AZ
85013
|
|
Applicant Contact |
JAMES J BERENS |
Correspondent |
MANY BEE CO. |
43 WEST ROSE LN. |
PHOENIX,
AZ
85013
|
|
Correspondent Contact |
JAMES J BERENS |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 07/22/1992 |
Decision Date | 04/20/1993 |
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
|
|
|