Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K883096 |
Device Name |
TRACHEAL TUBE LASER SHIELD KIT |
Applicant |
AMERICAL CORP. |
950FLANDERS RD. |
POST OFFICE BOX 334 |
MYSTIC,
CT
06355
|
|
Applicant Contact |
RON CERCONE |
Correspondent |
AMERICAL CORP. |
950FLANDERS RD. |
POST OFFICE BOX 334 |
MYSTIC,
CT
06355
|
|
Correspondent Contact |
RON CERCONE |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 07/22/1988 |
Decision Date | 09/08/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|