MITYVAC


Device Classification Name

extractor, vacuum, fetal

510(k) Number K011532
Device Name MITYVAC
Original Applicant
PRISM ENTERPRISES, INC.
555 thirteenth st. n.w.
washington, 
DC 
20004 -5600

Original Contact howard m holstein
Regulation Number 884.4340
Classification Product Code
HDB  
Date Received 05/18/2001
Decision Date 07/30/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls