Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K863606 |
Device Name |
BUTTERFLY NON-CORING NEEDLE SET |
Applicant |
CORMED, INC., SUB. C.R.BARD, INC. |
591 MAHAR ST. |
MEDINA,
NY
14103
|
|
Applicant Contact |
ANKERUD, JD |
Correspondent |
CORMED, INC., SUB. C.R.BARD, INC. |
591 MAHAR ST. |
MEDINA,
NY
14103
|
|
Correspondent Contact |
ANKERUD, JD |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 09/16/1986 |
Decision Date | 12/18/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|