Device Classification Name |
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
|
510(k) Number |
K771015 |
Device Name |
VYGON RED-O-PACK |
Applicant |
COASTAL BEND MEDICAL PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
COASTAL BEND MEDICAL PRODUCTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 06/06/1977 |
Decision Date | 07/11/1977 |
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
|
|
|