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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K911973
Device Name LINEAR ACCELERATOR COLLIMATOR
Applicant
Medical Equipment Development Co., Inc.
1001 Orchard Dr.
Cinnaminson,  NJ  08077
Applicant Contact ROBERTA PALMER
Correspondent
Medical Equipment Development Co., Inc.
1001 Orchard Dr.
Cinnaminson,  NJ  08077
Correspondent Contact ROBERTA PALMER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/03/1991
Decision Date 10/15/1992
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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