TYCO BABY SESAME STREET SOFT TEETHER— 510(k) K963912

Name: FDA 510(k) clearance K963912
Creator: U.S. Food and Drug Administration
Published: 1996-11-06

Substantially Equivalent

Regu-Tech Assoc., Inc.

FDA 510(k) clearance K963912 for TYCO BABY SESAME STREET SOFT TEETHER, Substantially Equivalent on 1996-11-06. Applicant: Regu-Tech Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Regu-Tech Assoc., Inc.
Product code: Code KKO
Device class: Class 2
Regulation: 21 CFR 872.5550
Advisory panel: Dental
Date received: 1996-09-30
Decision date: 1996-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKO

view all

K123855 — WATER-FILLED TEETHER2013-05-24
K110615 — WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE2011-12-02
K092025 — FLUID FILLED TEETHER - GEL2011-01-27
K093266 — MAM COOLER2010-07-27
K092781 — MAM TWISTER2010-06-23

More clearances from Regu-Tech Assoc., Inc.

view all

K971228 — FEMTEX 100% COTTON TAMPONS1997-04-09
K970232 — FEMTEX 100% COTTON DENTLE TOUCH TAMPONS1997-03-21

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