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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Support, Breathing Tube
510(k) Number K944988
Device Name CUSTOM MEDICAL SUSPENSION STRAP
Applicant
Custom Medical Specialties, Inc.
1445-P Brookville Way
Indianapolis,  IN  46239
Applicant Contact MIKE THOMAS
Correspondent
Custom Medical Specialties, Inc.
1445-P Brookville Way
Indianapolis,  IN  46239
Correspondent Contact MIKE THOMAS
Regulation Number868.5280
Classification Product Code
JAY  
Date Received10/12/1994
Decision Date 01/27/1995
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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