Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K180063 |
Device Name |
OCM-G1 Attachment |
Applicant |
The Anspach Effort, Inc. |
4500 Riverside Drive |
Palm Beach Gardens,
FL
33410
|
|
Applicant Contact |
Tamara J West |
Correspondent |
The Anspach Effort, Inc. |
4500 Riverside Drive |
Palm Beach Gardens,
FL
33410
|
|
Correspondent Contact |
Tamara J West |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 01/09/2018 |
Decision Date | 03/27/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|