Device Classification Name |
Mask, Gas, Anesthetic
|
510(k) Number |
K881393 |
Device Name |
RONDEX RESCUE MASK |
Applicant |
RONDEX PRODUCTS, INC. |
P.O. BOX NO. 1829 |
ROCKFORD,
IL
61110
|
|
Applicant Contact |
GENE R BALDWIN |
Correspondent |
RONDEX PRODUCTS, INC. |
P.O. BOX NO. 1829 |
ROCKFORD,
IL
61110
|
|
Correspondent Contact |
GENE R BALDWIN |
Regulation Number | 868.5550
|
Classification Product Code |
|
Date Received | 04/04/1988 |
Decision Date | 04/25/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|