Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K183009 |
Device Name |
HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES |
Applicant |
Hemostatix Medical Technologies, LLC |
8400 Wolf Lake Drive, STE 109 |
Bartlett,
TN
38133
|
|
Applicant Contact |
Jeff Cobb |
Correspondent |
Hemostatix Medical Technologies, LLC |
8400 Wolf Lake Drive, STE 109 |
Bartlett,
TN
38133
|
|
Correspondent Contact |
Jeff Cobb |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 10/31/2018 |
Decision Date | 11/26/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|