Device Classification Name |
Sheet, Burn
|
510(k) Number |
K760210 |
Device Name |
BLANKET, WATER-JEL FIRE |
Applicant |
AMERICAN SAFETY |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
AMERICAN SAFETY |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 880.5180
|
Classification Product Code |
|
Date Received | 07/12/1976 |
Decision Date | 08/11/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|