MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)


Device Classification Name

hysteroscope (and accessories)

510(k) Number K121868
Device Name MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
Applicant
HOLOGIC, INC.
250 campus drive
marlborough, 
MA 
01752

Applicant Contact sarah fairfield
Correspondent
HOLOGIC, INC.
250 campus drive
marlborough, 
MA 
01752

Correspodent Contact sarah fairfield
Regulation Number 884.1690
Classification Product Code
HIH  
Date Received 06/26/2012
Decision Date 07/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No