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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 K871935
Device Name T P C (TONOMETER PROBE COVER)
Applicant
Krb Ent.
10912 Pembroke Dr.
Santa Ana,  CA  92705
Applicant Contact KENNETH R BICE
Correspondent
Krb Ent.
10912 Pembroke Dr.
Santa Ana,  CA  92705
Correspondent Contact KENNETH R BICE
Regulation Number886.1930
Classification Product Code
HKX  
Date Received05/19/1987
Decision Date 06/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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