Device Classification Name |
Sampler, Amniotic Fluid (Amniocentesis Tray)
|
510(k) Number |
K862365 |
Device Name |
NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE |
Applicant |
SWEMED LABORATORIES, INC. |
FULLRIGGAREGATAN 12 B |
S-421 74 V.FROLUNDA |
SWEDEN,
SE
|
|
Applicant Contact |
GORAN ITSKOWITZ |
Correspondent |
SWEMED LABORATORIES, INC. |
FULLRIGGAREGATAN 12 B |
S-421 74 V.FROLUNDA |
SWEDEN,
SE
|
|
Correspondent Contact |
GORAN ITSKOWITZ |
Regulation Number | 884.1550
|
Classification Product Code |
|
Date Received | 06/24/1986 |
Decision Date | 07/07/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|