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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K923259
Device Name LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS
Applicant
IMTEC CORP.
3071 CONTINENTAL DR.
WEST PALM BEACH,  FL  33407
Applicant Contact MARK C HAMBLIN
Correspondent
IMTEC CORP.
3071 CONTINENTAL DR.
WEST PALM BEACH,  FL  33407
Correspondent Contact MARK C HAMBLIN
Regulation Number884.1720
Classification Product Code
HET  
Date Received07/02/1992
Decision Date 04/11/1994
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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