Device Classification Name |
wound dressing kit
|
510(k) Number |
K970721 |
Device Name |
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM |
Applicant |
JOHNSON & JOHNSON MEDICAL, INC. |
2500 E. ARBROOK BLVD. |
P.O. BOX 90130 |
ARLINGTON,
TX
76004 -3130
|
|
Applicant Contact |
WILLIAM P ROBB |
Correspondent |
JOHNSON & JOHNSON MEDICAL, INC. |
2500 E. ARBROOK BLVD. |
P.O. BOX 90130 |
ARLINGTON,
TX
76004 -3130
|
|
Correspondent Contact |
WILLIAM P ROBB |
Regulation Number | 880.5075
|
Classification Product Code |
|
Date Received | 02/27/1997 |
Decision Date | 03/21/1997 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|