Device Classification Name |
airway, nasopharyngeal
|
510(k) Number |
K940320 |
Device Name |
AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS |
Applicant |
AD-TECH MEDICAL INSTRUMENT CORP. |
1901 WILLIAM ST. |
RACINE,
WI
53404 -1876
|
|
Applicant Contact |
DAVID ANTHONY PUTZ |
Correspondent |
AD-TECH MEDICAL INSTRUMENT CORP. |
1901 WILLIAM ST. |
RACINE,
WI
53404 -1876
|
|
Correspondent Contact |
DAVID ANTHONY PUTZ |
Regulation Number | 868.5100
|
Classification Product Code |
|
Date Received | 01/24/1994 |
Decision Date | 09/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|