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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spreader, Cuff
510(k) Number K870600
Device Name SOFT EAR STETHOSCOPE
Applicant
Kalajian Ent.
6601 Turkey Farm Rd.
Chapel Hill,  NC  27514
Applicant Contact KALAYJIAN, MD
Correspondent
Kalajian Ent.
6601 Turkey Farm Rd.
Chapel Hill,  NC  27514
Correspondent Contact KALAYJIAN, MD
Regulation Number868.5760
Classification Product Code
CBG  
Date Received02/10/1987
Decision Date 03/19/1987
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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