Device Classification Name |
forceps, biopsy, gynecological
|
510(k) Number |
K011488 |
Device Name |
SPIRABRUSH CX BIOPSY INSTRUMENT |
Applicant |
TRYLON CORP. |
970 WEST 190TH ST., SUITE 850 |
TORRANCE,
CA
90502 -1037
|
|
Applicant Contact |
MARTIN LONKY |
Correspondent |
TRYLON CORP. |
970 WEST 190TH ST., SUITE 850 |
TORRANCE,
CA
90502 -1037
|
|
Correspondent Contact |
MARTIN LONKY |
Regulation Number | 884.4530
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/15/2001 |
Decision Date | 02/22/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|