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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 K951490
Device Name LASEVAC
Applicant
D.D. SURGICAL, INC.
404 MARVEL COURT
EASTON,  MD  21601
Applicant Contact L. T DIVILIO
Correspondent
D.D. SURGICAL, INC.
404 MARVEL COURT
EASTON,  MD  21601
Correspondent Contact L. T DIVILIO
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/31/1995
Decision Date 06/13/1995
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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