NOVA PILLOW

Orthosis, Cervical

NOVA HEALTH SYSTEMS, INC.

The following data is part of a premarket notification filed by Nova Health Systems, Inc. with the FDA for Nova Pillow.

Pre-market Notification Details

Device IDK895477
510k NumberK895477
Device Name:NOVA PILLOW
ClassificationOrthosis, Cervical
Applicant NOVA HEALTH SYSTEMS, INC. 1001 LOWER LANDING RD. SUITE 409 Blackwood,  NJ  08012
ContactRobert E Delano
CorrespondentRobert E Delano
NOVA HEALTH SYSTEMS, INC. 1001 LOWER LANDING RD. SUITE 409 Blackwood,  NJ  08012
Product CodeIQK  
CFR Regulation Number890.3490 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-11
Decision Date1990-01-10

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