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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name applier, surgical, clip
510(k) Number K772286
Device Name FORCEPS, SUTURE, AUTO
Applicant
HARTMANN GROUP, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HARTMANN GROUP, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GDO  
Date Received12/12/1977
Decision Date 12/20/1977
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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