Device Classification Name |
Extractor, Vacuum, Fetal
|
510(k) Number |
K011532 |
Device Name |
MITYVAC |
Applicant |
PRISM ENTERPRISES, INC. |
555 THIRTEENTH ST. N.W. |
WASHINGTON,
DC
20004 -5600
|
|
Applicant Contact |
HOWARD M HOLSTEIN |
Correspondent |
PRISM ENTERPRISES, INC. |
555 THIRTEENTH ST. N.W. |
WASHINGTON,
DC
20004 -5600
|
|
Correspondent Contact |
HOWARD M HOLSTEIN |
Regulation Number | 884.4340
|
Classification Product Code |
|
Date Received | 05/18/2001 |
Decision Date | 07/30/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|