Device Classification Name |
Accessory, Assisted Reproduction
|
510(k) Number |
K991216 |
Device Name |
HOFFMAN IVF-1 |
Applicant |
(ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION |
555 NORTH LN. |
SUITE 5001 |
CONSHOHOCKEN,
PA
19428
|
|
Applicant Contact |
FRANK STRZEMPEK |
Correspondent |
(ARMS) HOFFMAN SURGICAL EQUIPMENT, IVF DIVISION |
555 NORTH LN. |
SUITE 5001 |
CONSHOHOCKEN,
PA
19428
|
|
Correspondent Contact |
FRANK STRZEMPEK |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 04/09/1999 |
Decision Date | 08/05/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|