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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K923815
Device Name TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS
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 Number878.4040
Classification Product Code
FYA  
Date Received07/30/1992
Decision Date 03/31/1993
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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