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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aspirator, ultrasonic
510(k) Number K913848
Device Name SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR
Applicant
SHARPLAN LASERS, INC.
1 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact DOUGLASS MEAD
Correspondent
SHARPLAN LASERS, INC.
1 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact DOUGLASS MEAD
Classification Product Code
MGI  
Date Received08/27/1991
Decision Date 03/27/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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