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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suit, Surgical
510(k) Number K914615
Device Name BTP(TM) CENTRALINE(TM) SUIT
Applicant
Btp Industries, Inc.
P.O. Box 2357
S. Hamilton,  MA  01982
Applicant Contact GEORGE A HERBSTER
Correspondent
Btp Industries, Inc.
P.O. Box 2357
S. Hamilton,  MA  01982
Correspondent Contact GEORGE A HERBSTER
Regulation Number878.4040
Classification Product Code
FXO  
Date Received10/17/1991
Decision Date 05/05/1992
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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