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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Binder, Elastic
510(k) Number K921852
Device Name 4 SURE TM RECTAL TUBE
Applicant
Boston Pacific Medical, Inc.
636 Beacon St.
Unit 204
Boston,  MA  02215
Applicant Contact RANDAL GREEN
Correspondent
Boston Pacific Medical, Inc.
636 Beacon St.
Unit 204
Boston,  MA  02215
Correspondent Contact RANDAL GREEN
Regulation Number880.5160
Classification Product Code
KMO  
Date Received04/17/1992
Decision Date 10/08/1993
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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