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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tape and bandage, adhesive
510(k) Number K880964
Device Name POLYDERM PEC(TM), POROUS ELASTIC COVER
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 Number880.5240
Classification Product Code
KGX  
Date Received03/08/1988
Decision Date 03/17/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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