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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 K880153
Device Name POLYDERM A+B(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 Received01/13/1988
Decision Date 04/13/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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