Device Classification Name |
instrument, biopsy
|
510(k) Number |
K881957 |
Device Name |
HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT |
Applicant |
N-S MEDICAL PRODUCTS |
4435 S.W. 35TH TERRACE |
SUITE 360 |
GAINESVILLE,
FL
32608
|
|
Applicant Contact |
KEITH L STAHL |
Correspondent |
N-S MEDICAL PRODUCTS |
4435 S.W. 35TH TERRACE |
SUITE 360 |
GAINESVILLE,
FL
32608
|
|
Correspondent Contact |
KEITH L STAHL |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 05/10/1988 |
Decision Date | 05/20/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|