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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 K935639
Device Name INSUFFLATION TUBING STERILE AND NON-STERILE
Applicant
Charles Polo & Co., Inc.
12714 Hoover St.
Garden Grove,  CA  92841
Applicant Contact CHARLES SPINA
Correspondent
Charles Polo & Co., Inc.
12714 Hoover St.
Garden Grove,  CA  92841
Correspondent Contact CHARLES SPINA
Regulation Number884.1730
Classification Product Code
HIF  
Date Received11/23/1993
Decision Date 03/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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