RESTFUL NIGHTS, IST-APPLIANCE


Device Classification Name

device, anti-snoring

510(k) Number K021569
Device Name RESTFUL NIGHTS, IST-APPLIANCE
Original Applicant
OTTAWA DENTAL LABORATORY
p.o. box 4341
crofton, 
MD 
21114

Original Contact e.j. smith
Regulation Number 872.5570
Classification Product Code
LRK  
Date Received 05/14/2002
Decision Date 03/15/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No