Device Classification Name |
Wound Dressing Kit
|
510(k) Number |
K912116 |
Device Name |
PRESSURE SORE MANAGEMENT KIT |
Applicant |
MEDICAL DEVICE INSPECTION CO., INC. |
55 NORTHERN BLVD. |
SUITE 301 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
ALAN P SCHWARTZ |
Correspondent |
MEDICAL DEVICE INSPECTION CO., INC. |
55 NORTHERN BLVD. |
SUITE 301 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
ALAN P SCHWARTZ |
Regulation Number | 880.5075
|
Classification Product Code |
|
Date Received | 05/14/1991 |
Decision Date | 10/18/1991 |
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
|
|
|