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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Caliper, Ophthalmic
510(k) Number K813315
Device Name CALIPER-OPTHALMIC
Applicant
Design Research Assoc., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Design Research Assoc., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.4350
Classification Product Code
HOE  
Date Received11/24/1981
Decision Date 03/01/1982
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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