Device Classification Name |
nasopharyngoscope (flexible or rigid)
|
510(k) Number |
K061663 |
Device Name |
ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES |
Applicant |
RTC INC.-MEMCATH TECHNOLOGIES LLC |
1777 OAKDALE AVE., |
WEST ST. PAUL,
MN
55118
|
|
Applicant Contact |
MARC JAKER |
Correspondent |
RTC INC.-MEMCATH TECHNOLOGIES LLC |
1777 OAKDALE AVE., |
WEST ST. PAUL,
MN
55118
|
|
Correspondent Contact |
MARC JAKER |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 06/05/2006 |
Decision Date | 09/06/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|