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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K980050
Device Name MENTOR SKIN PROTECTION PAD
Applicant
MENTOR CORP.
5425 HOLLISTER AVE.
SANTA BARBARA,  CA  93111
Applicant Contact DONNA A CRAWFORD
Correspondent
MENTOR CORP.
5425 HOLLISTER AVE.
SANTA BARBARA,  CA  93111
Correspondent Contact DONNA A CRAWFORD
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/06/1998
Decision Date 02/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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