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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name marker, ocular
510(k) Number K872747
Device Name LASER CENTERING DEVICE
Applicant
INNOMED CORP.
620 LUNAR
BREA,  CA  92621
Applicant Contact PETER K BROWN
Correspondent
INNOMED CORP.
620 LUNAR
BREA,  CA  92621
Correspondent Contact PETER K BROWN
Regulation Number886.4570
Classification Product Code
HMR  
Date Received07/13/1987
Decision Date 09/04/1987
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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