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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 K921596
Device Name SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE
Applicant
Sharplan Lasers, Inc.
1 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact DOUGLASS MEAD
Correspondent
Sharplan Lasers, Inc.
1 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact DOUGLASS MEAD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/03/1992
Decision Date 05/13/1992
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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