Device Classification Name |
apparatus, suction, ward use, portable, ac-powered
|
510(k) Number |
K914694 |
Device Name |
STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU |
Applicant |
DEPUY, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
DAVID A KOTKOVETZ |
Correspondent |
DEPUY, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
DAVID A KOTKOVETZ |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 10/18/1991 |
Decision Date | 01/16/1992 |
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
|
|
|