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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Pediatric, General & Plastic Surgery
510(k) Number K802783
Device Name SURGEONS CHOICE STAPLE, REMOVE/IMPLANT
Applicant
Hospital Products Intl.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hospital Products Intl.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4200
Classification Product Code
GBN  
Date Received11/04/1980
Decision Date 12/16/1980
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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