Device Classification Name |
condenser, heat and moisture (artificial nose)
|
510(k) Number |
K893875 |
Device Name |
FLOCARE |
Applicant |
MEGA-TECH INTL., INC. |
175 STRAFFORD AVE. |
WAYNE,
PA
19087
|
|
Applicant Contact |
AL W KRAUS |
Correspondent |
MEGA-TECH INTL., INC. |
175 STRAFFORD AVE. |
WAYNE,
PA
19087
|
|
Correspondent Contact |
AL W KRAUS |
Regulation Number | 868.5375
|
Classification Product Code |
|
Date Received | 05/26/1989 |
Decision Date | 08/11/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|