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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K841813
Device Name TISSUE INTEGRATED PROSTHESIS DRILL
Applicant
BOFORS NOBELPHARMA, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BOFORS NOBELPHARMA, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.4250
Classification Product Code
ERL  
Date Received05/01/1984
Decision Date 08/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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