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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Uptake, Nuclear
510(k) Number K864263
Device Name NEOPROBE PORTABLE RADIOISOTOPE DETECTOR
Applicant
Neoprobe Corp.
2219 Summit St.
Columbus,  OH  43201
Applicant Contact DAVID CROCKFORD
Correspondent
Neoprobe Corp.
2219 Summit St.
Columbus,  OH  43201
Correspondent Contact DAVID CROCKFORD
Regulation Number892.1320
Classification Product Code
IZD  
Date Received10/29/1986
Decision Date 12/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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