Device Classification Name |
blade, scalpel
|
510(k) Number |
K923170 |
Device Name |
LOS ALAMOS RETRACTABLE KNIFE |
Applicant |
INNOVATIVE SURGICAL TECHNOLOGY, INC. |
901 18TH ST. |
P.O. BOX 148 |
LOS ALAMOS,
NM
87544
|
|
Applicant Contact |
MICHAEL JACKSON |
Correspondent |
INNOVATIVE SURGICAL TECHNOLOGY, INC. |
901 18TH ST. |
P.O. BOX 148 |
LOS ALAMOS,
NM
87544
|
|
Correspondent Contact |
MICHAEL JACKSON |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 06/29/1992 |
Decision Date | 02/18/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|