ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC


Device Classification Name

hysteroscope (and accessories)

510(k) Number K022480
Device Name ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
Original Applicant
ACMI CORPORATION
136 turnpike rd.
southborough, 
MA 
01772

Original Contact john a delucia
Regulation Number 884.1690
Classification Product Code
HIH  
Subsequent Product Code
HGI  
Date Received 07/26/2002
Decision Date 08/22/2002
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