INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM


Device Classification Name

hysteroscope (and accessories)

510(k) Number K073690
Device Name INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM
Applicant
INTERLACE MEDICAL, INC.
139 newbury street
framingham, 
MA 
01701

Applicant Contact ron adams
Correspondent
INTERLACE MEDICAL, INC.
139 newbury street
framingham, 
MA 
01701

Correspodent Contact ron adams
Regulation Number 884.1690
Classification Product Code
HIH  
Date Received 12/28/2007
Decision Date 04/17/2008
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