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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tonometer, ac-powered
510(k) Number K895575
Device Name BIO-RAD MODULAR AIR COMPRESSOR
Applicant
BIO-RAD
237 PUTNAM AVE.
CAMBRIDGE,  MA  02139
Applicant Contact DAVID P MACADAM
Correspondent
BIO-RAD
237 PUTNAM AVE.
CAMBRIDGE,  MA  02139
Correspondent Contact DAVID P MACADAM
Regulation Number886.1930
Classification Product Code
HKX  
Date Received09/14/1989
Decision Date 10/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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