Device Classification Name |
microtools, assisted reproduction (pipettes)
|
510(k) Number |
K983713 |
Device Name |
PRODIMED MICROINJECTION PIPETTES |
Applicant |
PRODIMED |
23 WELISEWITZ RD. |
RINGOES,
NJ
08551
|
|
Applicant Contact |
RANDOLPH L COOKE |
Correspondent |
PRODIMED |
23 WELISEWITZ RD. |
RINGOES,
NJ
08551
|
|
Correspondent Contact |
RANDOLPH L COOKE |
Regulation Number | 884.6130
|
Classification Product Code |
|
Date Received | 10/21/1998 |
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
|
|
|