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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K900945
Device Name LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING
Applicant
Palex Medical, Inc.
One Lethbridge Plz.
Suite 7
Mahwah,  NJ  07430
Applicant Contact KELLY, MD
Correspondent
Palex Medical, Inc.
One Lethbridge Plz.
Suite 7
Mahwah,  NJ  07430
Correspondent Contact KELLY, MD
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/28/1990
Decision Date 05/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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