Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K973286 |
Device Name |
ENT IRRIGATING PUMP (70327700) |
Applicant |
GYRUS ENT L.L.C. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Applicant Contact |
DEBORAH A ARTHUR |
Correspondent |
GYRUS ENT L.L.C. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Correspondent Contact |
DEBORAH A ARTHUR |
Regulation Number | 874.4250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/02/1997 |
Decision Date | 09/29/1997 |
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
|
|
|