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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827577
Device Name VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER
Applicant
Randwal Instrument Co., Inc.
P.O.Box A, 100 Mechanic St.
Southbridge,  MA  01550
Correspondent
Randwal Instrument Co., Inc.
P.O.Box A, 100 Mechanic St.
Southbridge,  MA  01550
Date Received12/20/1982
Decision Date 01/24/1983
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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