Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K981637 |
Device Name |
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY |
Applicant |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Applicant Contact |
CAROL A WEIDEMAN |
Correspondent |
LINVATEC CORP. |
11311 CONCEPT BLVD. |
LARGO,
FL
33773 -4908
|
|
Correspondent Contact |
CAROL A WEIDEMAN |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 05/08/1998 |
Decision Date | 07/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|