Device Classification Name |
balloon, epistaxis
|
510(k) Number |
K924542 |
Device Name |
NASAL-SINUS PACKING |
Applicant |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
P.O. BOX 326 |
NORTH STONINGTON,
CT
06359
|
|
Applicant Contact |
GEORGE P KORTEWEG |
Correspondent |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
P.O. BOX 326 |
NORTH STONINGTON,
CT
06359
|
|
Correspondent Contact |
GEORGE P KORTEWEG |
Regulation Number | 874.4100
|
Classification Product Code |
|
Date Received | 09/08/1992 |
Decision Date | 02/12/1993 |
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
|
|
|