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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K945430
Device Name DERMAVBLADE(TM)
Applicant
Hasting'S Biomedical Corp.
2726 Curved Creek Rd.
Quincy,  IL  62301
Applicant Contact ROBERT J SEGAL
Correspondent
Hasting'S Biomedical Corp.
2726 Curved Creek Rd.
Quincy,  IL  62301
Correspondent Contact ROBERT J SEGAL
Regulation Number878.4800
Classification Product Code
MDM  
Date Received08/23/1994
Decision Date 11/28/1994
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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