Device Classification Name |
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
|
510(k) Number |
K813394 |
Device Name |
DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM |
Applicant |
COX-UPHUFF INTL. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
COX-UPHUFF INTL. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 880.6740 |
Classification Product Code |
|
Date Received | 12/04/1981 |
Decision Date | 01/22/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|