Device Classification Name |
tape, measuring, rulers and calipers
|
510(k) Number |
K951064 |
Device Name |
DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC |
Applicant |
S-E SALES & DISTRIBUTION, INC. |
P.O. BOX 131 |
POULTNEY,
VT
05764 -0131
|
|
Applicant Contact |
RICHARD J FRANK |
Correspondent |
S-E SALES & DISTRIBUTION, INC. |
P.O. BOX 131 |
POULTNEY,
VT
05764 -0131
|
|
Correspondent Contact |
RICHARD J FRANK |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 03/08/1995 |
Decision Date | 05/19/1995 |
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
|
|
|