Device Classification Name |
syringe, irrigating (non dental)
|
510(k) Number |
K881020 |
Device Name |
SURGICAL SEALANT DISPENSER (SSD) |
Applicant |
MICROMEDICS, INC. |
268 E. LAFAYETTE FRONTAGE |
ROAD |
ST. PAUL,
MN
55107
|
|
Applicant Contact |
CURT MILLER |
Correspondent |
MICROMEDICS, INC. |
268 E. LAFAYETTE FRONTAGE |
ROAD |
ST. PAUL,
MN
55107
|
|
Correspondent Contact |
CURT MILLER |
Regulation Number | 880.6960
|
Classification Product Code |
|
Date Received | 03/10/1988 |
Decision Date | 03/25/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|