Device Classification Name |
labware, assisted reproduction
|
510(k) Number |
K000915 |
Device Name |
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 |
Applicant |
HUMAGEN FERTILITY DIAGNOSTICS, INC. |
2400 HUNTER'S WAY |
CHARLOTTESVILLE,
VA
22911
|
|
Applicant Contact |
CINDY SHOWALTER |
Correspondent |
HUMAGEN FERTILITY DIAGNOSTICS, INC. |
2400 HUNTER'S WAY |
CHARLOTTESVILLE,
VA
22911
|
|
Correspondent Contact |
CINDY SHOWALTER |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 03/22/2000 |
Decision Date | 05/12/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|