Device Classification Name |
circuit, breathing (w connector, adaptor, y piece)
|
510(k) Number |
K852405 |
Device Name |
LASERSAFE PERSONNEL AND PATIENT SHIELDS |
Applicant |
LASERSAFE, INC. |
641 RIDGEFIELD AVE. |
PITTSBURGH,
PA
15216
|
|
Applicant Contact |
TEEPLE, M.D. |
Correspondent |
LASERSAFE, INC. |
641 RIDGEFIELD AVE. |
PITTSBURGH,
PA
15216
|
|
Correspondent Contact |
TEEPLE, M.D. |
Regulation Number | 868.5240
|
Classification Product Code |
|
Date Received | 06/06/1985 |
Decision Date | 10/01/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|