Atlas FDA

MODERN MEDICAL RESECTOSCOPE ELECTRODES

FDA 510(k) clearance K091511 · decided 2010-01-15

Clearance details

K-number
K091511
Device name
MODERN MEDICAL RESECTOSCOPE ELECTRODES
Applicant
Modern Medical Equipment Mfg., Ltd.
Decision
Substantially Equivalent
Date received
2009-05-22
Decision date
2010-01-15
Days to decision
238 days
Clearance type
Traditional
Product code
FAS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Kwai Chung, Hong Kong, CN
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.