Device Classification Name |
Apparatus, Suction, Ward Use, Portable, Ac-Powered
|
510(k) Number |
K974038 |
Device Name |
THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT |
Applicant |
A & A MEDICAL, INC. |
4100 NINE MCFARLAND DR., #B |
ALPHARETTA,
GA
30201
|
|
Applicant Contact |
JIHAD MANSOUR |
Correspondent |
A & A MEDICAL, INC. |
4100 NINE MCFARLAND DR., #B |
ALPHARETTA,
GA
30201
|
|
Correspondent Contact |
JIHAD MANSOUR |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 10/24/1997 |
Decision Date | 05/11/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|