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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 K954674
Device Name P1OP2B OR P1O92T
Applicant
Kay Borch A/S
15135 Memorial Dr.
Apt. 8301
Houston,  TX  77079
Applicant Contact MICHAEL MOSEGAARD
Correspondent
Kay Borch A/S
15135 Memorial Dr.
Apt. 8301
Houston,  TX  77079
Correspondent Contact MICHAEL MOSEGAARD
Regulation Number878.4040
Classification Product Code
FYA  
Date Received10/10/1995
Decision Date 01/30/1997
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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