Device Classification Name |
mask, gas, anesthetic
|
510(k) Number |
K850263 |
Device Name |
PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY |
Applicant |
PLASMEDICS, INC. |
638 MAIN ST. |
ASHLAND,
MA
01721
|
|
Applicant Contact |
JEROME L KRASNER |
Correspondent |
PLASMEDICS, INC. |
638 MAIN ST. |
ASHLAND,
MA
01721
|
|
Correspondent Contact |
JEROME L KRASNER |
Regulation Number | 868.5550
|
Classification Product Code |
|
Date Received | 01/23/1985 |
Decision Date | 03/25/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|