Device Classification Name |
Gauze/Sponge, Internal, X-Ray Detectable
|
510(k) Number |
K945336 |
Device Name |
PEANUT DISSECTOR |
Applicant |
LORREX HEALTH PRODUCTS |
301 PENHORN AVE. |
SECAUCUS,
NJ
07094
|
|
Applicant Contact |
DAVID M PIERATOS |
Correspondent |
LORREX HEALTH PRODUCTS |
301 PENHORN AVE. |
SECAUCUS,
NJ
07094
|
|
Correspondent Contact |
DAVID M PIERATOS |
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 11/01/1994 |
Decision Date | 12/05/1994 |
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
|