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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Restraint, Protective
510(k) Number K963138
Device Name SPIDER STRAP
Applicant
Bdm Medical, Inc.
518 Main St.
P.O. Box 515
Ashton,  ID  83420
Applicant Contact BONNIE J BURLAGE
Correspondent
Bdm Medical, Inc.
518 Main St.
P.O. Box 515
Ashton,  ID  83420
Correspondent Contact BONNIE J BURLAGE
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received08/13/1996
Decision Date 11/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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