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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K894066
Device Name SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX
Applicant
Sharplan Lasers, Inc.
1 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact KENNETH RAICHMAN
Correspondent
Sharplan Lasers, Inc.
1 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact KENNETH RAICHMAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/08/1989
Decision Date 08/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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