Device Classification Name |
microtools, assisted reproduction (pipettes)
|
510(k) Number |
K001615 |
Device Name |
HUNTER SCIENTIFIC INJECTION PIPETTES |
Applicant |
HUNTER SCIENTIFIC LIMITED |
UNIT 1, PRIORS HALL, |
WIDDINGTON |
SAFFRON WALDEN, ESSEX,
GB
CB113SB
|
|
Applicant Contact |
MARK RAWE |
Correspondent |
HUNTER SCIENTIFIC LIMITED |
UNIT 1, PRIORS HALL, |
WIDDINGTON |
SAFFRON WALDEN, ESSEX,
GB
CB113SB
|
|
Correspondent Contact |
MARK RAWE |
Regulation Number | 884.6130
|
Classification Product Code |
|
Date Received | 05/25/2000 |
Decision Date | 08/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|