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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 K915430
Device Name SKIN STAPLE REMOVER KIT
Applicant
Cypress Medical Products, Ltd.
1202 S. Rte. 31
Mc Henry,  IL  60050
Applicant Contact VARUN SONI
Correspondent
Cypress Medical Products, Ltd.
1202 S. Rte. 31
Mc Henry,  IL  60050
Correspondent Contact VARUN SONI
Regulation Number878.4760
Classification Product Code
GDT  
Date Received12/02/1991
Decision Date 02/28/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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