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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 K861044
Device Name MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND
Applicant
Sharplan Industries, Inc.
C/O Kleinfeld, Kaplan & Becker
1140 Nineteenth St., NW
Washington,  DC  20036
Applicant Contact PETER SAFIR
Correspondent
Sharplan Industries, Inc.
C/O Kleinfeld, Kaplan & Becker
1140 Nineteenth St., NW
Washington,  DC  20036
Correspondent Contact PETER SAFIR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/18/1986
Decision Date 10/28/1986
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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