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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Scalpel
510(k) Number K851157
Device Name SURGIMED - SURGICAL BLADES
Applicant
Surgimed Corp.
One Oak Borrk Terrance #500
22nd. At Butterfield Rd.
Oakbrook Terrance,  IL  60181
Applicant Contact PARVEZ SHIRZAI
Correspondent
Surgimed Corp.
One Oak Borrk Terrance #500
22nd. At Butterfield Rd.
Oakbrook Terrance,  IL  60181
Correspondent Contact PARVEZ SHIRZAI
Regulation Number878.4800
Classification Product Code
GES  
Date Received03/22/1985
Decision Date 04/25/1985
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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