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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K882332
Device Name HEADREST, PATIENT COMFORT
Applicant
Surgic Aid, Inc.
576 Mammoth Rd. (Rd1)
Londonderry,  NH  03053
Applicant Contact PAUL W O'REILLY
Correspondent
Surgic Aid, Inc.
576 Mammoth Rd. (Rd1)
Londonderry,  NH  03053
Correspondent Contact PAUL W O'REILLY
Regulation Number880.6060
Classification Product Code
KME  
Date Received06/06/1988
Decision Date 07/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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