Device Classification Name |
Irrigator, Sinus
|
510(k) Number |
K931398 |
Device Name |
GM SWIVEL VIDEO (TM) IRRIGATOR |
Applicant |
GM ENGINEERING, INC. |
2549 SIERRA WAY, SUITE B |
LA VERNE,
CA
91750
|
|
Applicant Contact |
DAVID STEFFIN |
Correspondent |
GM ENGINEERING, INC. |
2549 SIERRA WAY, SUITE B |
LA VERNE,
CA
91750
|
|
Correspondent Contact |
DAVID STEFFIN |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 03/19/1993 |
Decision Date | 08/30/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|