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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Sonic And Accessory/Attachment
510(k) Number K800501
Device Name PFIZER/AS&E 0450 LOCALIZER
Applicant
Pfizer Medical Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pfizer Medical Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.4580
Classification Product Code
JDX  
Date Received03/04/1980
Decision Date 04/10/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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