Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K961192 |
Device Name |
IRRIGATION SYSTEM |
Applicant |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Applicant Contact |
CAROL A WEIDERMAN |
Correspondent |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Correspondent Contact |
CAROL A WEIDERMAN |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 03/26/1996 |
Decision Date | 04/26/1996 |
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
|
|
|