Device Classification Name |
Mask, Oxygen, Non-Rebreathing
|
510(k) Number |
K930336 |
Device Name |
PROFAST(R)-DENTURE ADHESIVE CREAM |
Applicant |
FITTYDENT-ALTWIRTH & SCHMITT GMBH |
333 WEST WACLER DR. SIOTE 2600 |
CHICAGO,
IL
60606
|
|
Applicant Contact |
THOMAS J MULDOON |
Correspondent |
FITTYDENT-ALTWIRTH & SCHMITT GMBH |
333 WEST WACLER DR. SIOTE 2600 |
CHICAGO,
IL
60606
|
|
Correspondent Contact |
THOMAS J MULDOON |
Regulation Number | 868.5570
|
Classification Product Code |
|
Date Received | 01/22/1993 |
Decision Date | 08/24/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|