SILENTSLEEP— 510(k) K801927

Substantially Equivalent

Slumber Research, Inc.

FDA 510(k) clearance K801927 for SILENTSLEEP, Substantially Equivalent on 1980-11-14. Applicant: Slumber Research, Inc.. Device class: 1.

Clearance details

Applicant: Slumber Research, Inc.
Product code: Code DYN
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1980-08-12
Decision date: 1980-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYN

K940769 — DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR1994-08-17
K935616 — SALIVA EJECTOR DISPOSABLE1994-03-21
K935758 — HYGOFLEX SALIVA-EJECTOR1994-03-21
K924211 — EJECTOR1993-03-31
K920492 — HIGH VAC1992-05-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.