Device Classification Name |
Labware, Assisted Reproduction
|
510(k) Number |
K052457 |
FOIA Releasable 510(k) |
K052457
|
Device Name |
PICSI SPERM SELECTION DEVICE |
Applicant |
BIOCOAT, INC. |
211 WITMER RD. |
HORSHAM,
PA
19044
|
|
Applicant Contact |
JAMES B JOHNSTON |
Correspondent |
BIOCOAT, INC. |
211 WITMER RD. |
HORSHAM,
PA
19044
|
|
Correspondent Contact |
JAMES B JOHNSTON |
Regulation Number | 884.6160
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/07/2005 |
Decision Date | 04/13/2006 |
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 |
Yes
|
|
|