Device Classification Name |
Laryngoscope, Rigid
|
510(k) Number |
K883414 |
FOIA Releasable 510(k) |
K883414
|
Device Name |
LARYNGOSCOPE BLADES |
Applicant |
TRUPHATEK, LTD. |
P.O. BOX 8051 |
NETANYA,
IL
42106
|
|
Applicant Contact |
DAVID GREY |
Correspondent |
TRUPHATEK, LTD. |
P.O. BOX 8051 |
NETANYA,
IL
42106
|
|
Correspondent Contact |
DAVID GREY |
Regulation Number | 868.5540
|
Classification Product Code |
|
Date Received | 08/15/1988 |
Decision Date | 08/19/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|