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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Occlusive
510(k) Number K890940
Device Name MODIFIED LABELING FOR POLYDERM WBC(TM)
Applicant
Laivan Corp.
49 Front St.
P.O. Box 175
East Rockaway,  NY  11518
Applicant Contact JOEL MARTZ
Correspondent
Laivan Corp.
49 Front St.
P.O. Box 175
East Rockaway,  NY  11518
Correspondent Contact JOEL MARTZ
Regulation Number878.4020
Classification Product Code
NAD  
Date Received02/22/1989
Decision Date 04/17/1989
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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