Device Classification Name |
kit, surgical instrument, disposable
|
510(k) Number |
K914244 |
Device Name |
STERILE CUSTOM SURGICAL KITS |
Applicant |
ULTI-MED INTL., INC. |
1688 GLEN ELLYN RD. |
GLENDALE HEIGHTS,
IL
60139
|
|
Applicant Contact |
DAVID INSCO |
Correspondent |
ULTI-MED INTL., INC. |
1688 GLEN ELLYN RD. |
GLENDALE HEIGHTS,
IL
60139
|
|
Correspondent Contact |
DAVID INSCO |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 09/23/1991 |
Decision Date | 02/24/1992 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|