Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K943108 |
Device Name |
MEDNEXT MICRO-DRILL |
Applicant |
MEDNEXT, INC. |
2000 AVENUE "P", SUITE 8 |
RIVIERA BEACH,
FL
33404
|
|
Applicant Contact |
THOMAS J MICKEL, PH.D. |
Correspondent |
MEDNEXT, INC. |
2000 AVENUE "P", SUITE 8 |
RIVIERA BEACH,
FL
33404
|
|
Correspondent Contact |
THOMAS J MICKEL, PH.D. |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 06/29/1994 |
Decision Date | 08/17/1994 |
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
|
|
|