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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K981756
Device Name SHELHIGH NO-REACT PNEUMOPLEDGETS
Applicant
Shelhigh, Inc.
67-71 E. Willow St.
Millburn,  NJ  07041
Applicant Contact SHLOMO GABBAY
Correspondent
Shelhigh, Inc.
67-71 E. Willow St.
Millburn,  NJ  07041
Correspondent Contact SHLOMO GABBAY
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/18/1998
Decision Date 08/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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