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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Nasal, Oxygen
510(k) Number K922397
Device Name 4 SURE TM NASAL OXYGEN CANNULA
Applicant
Boston Pacific Medical, Inc.
636 Beacon St.
Unit 204
Boston,  MA  02215
Applicant Contact RANDALL GREEN
Correspondent
Boston Pacific Medical, Inc.
636 Beacon St.
Unit 204
Boston,  MA  02215
Correspondent Contact RANDALL GREEN
Regulation Number868.5340
Classification Product Code
CAT  
Date Received05/21/1992
Decision Date 03/18/1993
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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