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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Cervical
510(k) Number K895477
Device Name NOVA PILLOW
Applicant
Nova Health Systems, Inc.
1001 Lower Landing Rd.
Suite 409
Blackwood,  NJ  08012
Applicant Contact ROBERT E DELANO
Correspondent
Nova Health Systems, Inc.
1001 Lower Landing Rd.
Suite 409
Blackwood,  NJ  08012
Correspondent Contact ROBERT E DELANO
Regulation Number890.3490
Classification Product Code
IQK  
Date Received09/11/1989
Decision Date 01/10/1990
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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