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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827035
Device Name OCULAR BIOMETER 4000
Applicant
Radionics Medical, Inc.
390 Steelcase Rd., E. Markham
Ontario L3r 1g2,  CA
Correspondent
Radionics Medical, Inc.
390 Steelcase Rd., E. Markham
Ontario L3r 1g2,  CA
Date Received04/23/1982
Decision Date 07/22/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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