Device Classification Name |
chamber, oxygen, topical, extremity
|
510(k) Number |
K861593 |
Device Name |
TOPICAL HYPERBARIC OXYGEN CHAMBER |
Applicant |
STEPHENSON INDUSTRIES, INC. |
P. O. BOX 1000 |
FARMINGDALE,
NJ
07727
|
|
Applicant Contact |
R. A LASLEY |
Correspondent |
STEPHENSON INDUSTRIES, INC. |
P. O. BOX 1000 |
FARMINGDALE,
NJ
07727
|
|
Correspondent Contact |
R. A LASLEY |
Regulation Number | 878.5650
|
Classification Product Code |
|
Date Received | 04/29/1986 |
Decision Date | 05/12/1986 |
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
|
|
|