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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dissector, surgical, general & plastic surgery
510(k) Number K831912
Device Name ROUND-BEEHIVE- DISSECTORS 3/8
Applicant
ORMED MFG., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ORMED MFG., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GDI  
Date Received06/14/1983
Decision Date 10/31/1983
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
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