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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K933873
Device Name CONCEPT UNIVERSAL PUMP SYSTEM
Applicant
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Applicant Contact MARTHA C MILLER
Correspondent
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Correspondent Contact MARTHA C MILLER
Regulation Number884.1700
Classification Product Code
HIG  
Subsequent Product Code
BTA  
Date Received08/09/1993
Decision Date 12/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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