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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 K910340
Device Name LAPAROSCOPIC ASPIRATION PROBE
Applicant
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Applicant Contact LEO L BASTA
Correspondent
Davol, Inc.
100 Sockanossett Crossroad
P.O. Box 8500
Cranston,  RI  02920
Correspondent Contact LEO L BASTA
Regulation Number884.1720
Classification Product Code
HET  
Date Received01/28/1991
Decision Date 02/26/1991
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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