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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K837028
Device Name PARKINSON NEUROSURGICAL HEADCLAMP FOR SERIAL ANGIOGRAPHY
Applicant
Ohio Medical Instrument Co., Inc.
3924 Virginia Ave.
Cincinnati,  OH  45227
Correspondent
Ohio Medical Instrument Co., Inc.
3924 Virginia Ave.
Cincinnati,  OH  45227
Date Received12/10/1982
Decision Date 03/09/1983
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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