Device Classification Name |
Wound Dressing Kit
|
510(k) Number |
K924690 |
Device Name |
VARIOUS NON-STERILE CUSTOM TRAYS/KITS |
Applicant |
SURGIPRO CENTRAL, INC. |
C/O PAT LAMB & ASSOCIATES |
P.O. BOX 431 |
TARPON SPRINGS,
FL
34689
|
|
Applicant Contact |
PATRICK J LAMB |
Correspondent |
SURGIPRO CENTRAL, INC. |
C/O PAT LAMB & ASSOCIATES |
P.O. BOX 431 |
TARPON SPRINGS,
FL
34689
|
|
Correspondent Contact |
PATRICK J LAMB |
Regulation Number | 880.5075
|
Classification Product Code |
|
Date Received | 09/17/1992 |
Decision Date | 07/16/1993 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|