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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 Plz.
Mahwah,  NJ  07430
Applicant Contact BRENDA M KELLY
Correspondent
Matsutani Seisakusho Co. , Ltd.
C/O The Lahr Consulting Group
One Lethbridge Plz.
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
Predetermined Change
Control Plan Authorized		 No
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