Device Classification Name |
Tray, Surgical, Instrument
|
510(k) Number |
K861525 |
Device Name |
DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS |
Applicant |
D & D PRODUCTS, INC. |
3711 LONG BEACH BOULEVARD, |
SUITE 618 |
LONG BEACH,
CA
90807
|
|
Applicant Contact |
DENNIS PACK |
Correspondent |
D & D PRODUCTS, INC. |
3711 LONG BEACH BOULEVARD, |
SUITE 618 |
LONG BEACH,
CA
90807
|
|
Correspondent Contact |
DENNIS PACK |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 04/18/1986 |
Decision Date | 05/06/1986 |
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
|
|
|