Device Classification Name |
catheter, peritoneal
|
510(k) Number |
K811378 |
Device Name |
PERCUTANEOUS DRAINING CATHETER |
Applicant |
MEDI-TECH, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
MEDI-TECH, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 05/15/1981 |
Decision Date | 06/02/1981 |
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
|
Recalls |
CDRH Recalls
|
|
|