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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Disposable
510(k) Number K854897
Device Name MAX-I-GRASP
Applicant
Euro-Med Intl.
Advanced Biosearch Associates
3880 Blackhawk Rd.
Danville,  CA  94526
Applicant Contact DONALD HOLSTEN
Correspondent
Euro-Med Intl.
Advanced Biosearch Associates
3880 Blackhawk Rd.
Danville,  CA  94526
Correspondent Contact DONALD HOLSTEN
Regulation Number878.4800
Classification Product Code
KDC  
Date Received12/06/1985
Decision Date 05/02/1986
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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