Device Classification Name |
Resectoscope
|
510(k) Number |
K936038 |
Device Name |
SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) |
Applicant |
SURGICAL LASER TECHNOLOGIES, INC. |
200 CRESSON BLVD. |
P.O.BOX 880 |
OAKS,
PA
19456 -0880
|
|
Applicant Contact |
THOMAS BECZE |
Correspondent |
SURGICAL LASER TECHNOLOGIES, INC. |
200 CRESSON BLVD. |
P.O.BOX 880 |
OAKS,
PA
19456 -0880
|
|
Correspondent Contact |
THOMAS BECZE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/20/1993 |
Decision Date | 05/27/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|