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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Insufflator, Laparoscopic
510(k) Number K021247
Device Name PNEUMOPERITONEUM INSUFFLATION NEEDLE
Applicant
MECTRA LABS, INC.
P.O. BOX 350
BLOOMFIELD,  IN  47424
Applicant Contact CHARLES E ALLGOOD
Correspondent
MECTRA LABS, INC.
P.O. BOX 350
BLOOMFIELD,  IN  47424
Correspondent Contact CHARLES E ALLGOOD
Regulation Number884.1730
Classification Product Code
HIF  
Date Received04/19/2002
Decision Date 11/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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