Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K932045 |
Device Name |
DISPOSABLE INSUFFLATION TUBING |
Applicant |
LASER, INC. |
P.O. BOX 358 |
TOMBALL,
TX
77375
|
|
Applicant Contact |
KEITH PRZYBYLA |
Correspondent |
LASER, INC. |
P.O. BOX 358 |
TOMBALL,
TX
77375
|
|
Correspondent Contact |
KEITH PRZYBYLA |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/27/1993 |
Decision Date | 09/23/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|