Device Classification Name |
Single-Use Reprocessed Ultrasonic Surgical Instruments
|
510(k) Number |
K050343 |
Device Name |
REPROCESSED HARMONIC SCALPELS |
Applicant |
STERILMED, INC. |
11400 73RD. AVE. N. STE. 100 |
MAPLE GROVE,
MN
55369
|
|
Applicant Contact |
BRUCE LESTER |
Correspondent |
STERILMED, INC. |
11400 73RD. AVE. N. STE. 100 |
MAPLE GROVE,
MN
55369
|
|
Correspondent Contact |
BRUCE LESTER |
Classification Product Code |
|
Date Received | 02/11/2005 |
Decision Date | 04/12/2005 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|