Device Classification Name |
Needle, Assisted Reproduction
|
510(k) Number |
K990913 |
Device Name |
HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU |
Applicant |
LABORATOIRES PRODIMED |
23 WELISEWITZ RD. |
RINGOES,
NJ
08551
|
|
Applicant Contact |
RANDOLPH L COOKE |
Correspondent |
LABORATOIRES PRODIMED |
23 WELISEWITZ RD. |
RINGOES,
NJ
08551
|
|
Correspondent Contact |
RANDOLPH L COOKE |
Regulation Number | 884.6100
|
Classification Product Code |
|
Date Received | 03/18/1999 |
Decision Date | 06/08/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|