INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM


Device Classification Name

hysteroscope (and accessories)

510(k) Number K081070
Device Name INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY 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 04/15/2008
Decision Date 07/23/2008
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