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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K930338
Device Name ORTHOCEPH OC100
Applicant
Instrumentarium Corp.
P.O. Box 20 (Nahkelentie 160)
Sf-04301
Tuusula,  FI
Applicant Contact RISTO MYNTTINEN
Correspondent
Instrumentarium Corp.
P.O. Box 20 (Nahkelentie 160)
Sf-04301
Tuusula,  FI
Correspondent Contact RISTO MYNTTINEN
Regulation Number872.1800
Classification Product Code
EHD  
Date Received01/25/1993
Decision Date 04/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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