Device Classification Name |
mask, oxygen
|
510(k) Number |
K870206 |
Device Name |
CRYSTAL MASK |
Applicant |
BRUNSWICK MFG. CO., INC. |
90 MYRTLE ST. |
NORTH QUINCY,
MA
02171
|
|
Applicant Contact |
ROY H HEWSON |
Correspondent |
BRUNSWICK MFG. CO., INC. |
90 MYRTLE ST. |
NORTH QUINCY,
MA
02171
|
|
Correspondent Contact |
ROY H HEWSON |
Regulation Number | 868.5580
|
Classification Product Code |
|
Date Received | 01/20/1987 |
Decision Date | 02/20/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|