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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K924995
Device Name 4 SURE TM ANESTHESIA EXTENSION SET
Applicant
Boston Pacific Medical, Inc.
451 D St.
Suite 811
Boston,  MA  02210
Applicant Contact RICHARD A DEROSA
Correspondent
Boston Pacific Medical, Inc.
451 D St.
Suite 811
Boston,  MA  02210
Correspondent Contact RICHARD A DEROSA
Regulation Number868.5120
Classification Product Code
BSO  
Date Received10/01/1992
Decision Date 12/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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