Device Classification Name |
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
|
510(k) Number |
K960099 |
Device Name |
PENROSE DRAIN MODELS 6001 - 6007 |
Applicant |
SIL-MED CORP. |
700 WARNER BLVD. |
TAUNTON,
MA
02780
|
|
Applicant Contact |
KAREN K SYLVIA |
Correspondent |
SIL-MED CORP. |
700 WARNER BLVD. |
TAUNTON,
MA
02780
|
|
Correspondent Contact |
KAREN K SYLVIA |
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 01/11/1996 |
Decision Date | 03/11/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|