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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Pressure Measurement, Intermittent
510(k) Number K881284
Device Name COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE
Applicant
Nathaniel Gould Diagnostics, Inc.
121 N. Plains Industrial Rd.
Unit L
Wallingford,  CT  06492
Applicant Contact GREG HUTCHESON
Correspondent
Nathaniel Gould Diagnostics, Inc.
121 N. Plains Industrial Rd.
Unit L
Wallingford,  CT  06492
Correspondent Contact GREG HUTCHESON
Regulation Number890.1600
Classification Product Code
JFC  
Date Received03/25/1988
Decision Date 07/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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