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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, removable (skin)
510(k) Number K861711
Device Name SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE
Applicant
BUSSE HOSPITAL DISPOSABLES, INC.
P.O. BOX 11067
HAUPPAUGE,  NY  11788
Applicant Contact PARTHA BASUMALLIK
Correspondent
BUSSE HOSPITAL DISPOSABLES, INC.
P.O. BOX 11067
HAUPPAUGE,  NY  11788
Correspondent Contact PARTHA BASUMALLIK
Regulation Number878.4760
Classification Product Code
GDT  
Date Received05/05/1986
Decision Date 05/16/1986
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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