Device Classification Name |
dressing, wound and burn, hydrogel w/drug and/or biologic
|
510(k) Number |
K990178 |
Device Name |
BURNFREE PAIN RELIEVING GEL, MODEL 4B |
Applicant |
NORTRADE MEDICAL, INC. |
9382 SOUTH 670 WEST |
SANDY,
UT
84070
|
|
Applicant Contact |
JAY W TAYLOR |
Correspondent |
NORTRADE MEDICAL, INC. |
9382 SOUTH 670 WEST |
SANDY,
UT
84070
|
|
Correspondent Contact |
JAY W TAYLOR |
Classification Product Code |
|
Date Received | 01/20/1999 |
Decision Date | 08/13/1999 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|