Device Classification Name |
Cap, Surgical
|
510(k) Number |
K873830 |
Device Name |
TECNOL SURGEON'S CAP |
Applicant |
TECNOL NEW JERSEY WOUND CARE, INC. |
7450 WHITEHALL ST. |
FT. WORTH,
TX
76012
|
|
Applicant Contact |
DAVID ARCHER |
Correspondent |
TECNOL NEW JERSEY WOUND CARE, INC. |
7450 WHITEHALL ST. |
FT. WORTH,
TX
76012
|
|
Correspondent Contact |
DAVID ARCHER |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 09/21/1987 |
Decision Date | 10/23/1987 |
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
|
|
|