Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K914912 |
Device Name |
PROMEON 63B SURGICAL TAPE |
Applicant |
PROMEON |
6700 SHINGLE CREEK PKWY. |
BROOKLYN CENTER,
MN
55430
|
|
Applicant Contact |
DAVID H MUELLER |
Correspondent |
PROMEON |
6700 SHINGLE CREEK PKWY. |
BROOKLYN CENTER,
MN
55430
|
|
Correspondent Contact |
DAVID H MUELLER |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 11/01/1991 |
Decision Date | 12/04/1991 |
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
|