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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Non-Rigid
510(k) Number K872895
Device Name HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.
Applicant
HAEMONETICS CORP.
400 WOOD RD.
P.O. BOX 9114
BRAINTREE,  MA  02184
Applicant Contact DIANA G TOWER
Correspondent
HAEMONETICS CORP.
400 WOOD RD.
P.O. BOX 9114
BRAINTREE,  MA  02184
Correspondent Contact DIANA G TOWER
Regulation Number868.5530
Classification Product Code
CAL  
Date Received07/23/1987
Decision Date 01/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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