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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 K925526
Device Name MANIPLER DISPOSABLE SKIN STAPLER
Applicant
MATSUTANI SEISAKUSHO CO. LTD.
C/O THE LAHR CONSULTING GROUP
ONE LETHBRIDGE PLAZA
MAHWAH,  NJ  07430
Applicant Contact BRENDA M KELLY
Correspondent
MATSUTANI SEISAKUSHO CO. LTD.
C/O THE LAHR CONSULTING GROUP
ONE LETHBRIDGE PLAZA
MAHWAH,  NJ  07430
Correspondent Contact BRENDA M KELLY
Regulation Number878.4760
Classification Product Code
GDT  
Date Received11/02/1992
Decision Date 06/24/1993
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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