510(k) K851640

Device: Tip Toledo Incisor Protector
Applicant: EDWARD O. GOODWICH
510(k) number: K851640
Product code: BRW
Decision: Substantially Equivalent (SESE)
Decision date: 1985-09-18
Date received: 1985-04-11
Regulation: 868.5820
Classification name: Protector, Dental
Medical specialty: Anesthesiology
Review panel: Anesthesiology
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Contact: EDWARD O GOODWICH
Address: 1600 Hagys Rd. 5v Narberth PA US 19072 19072

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BRW#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K945727	CATCO NEONATAL PALATE GUARD	Catco Medical, Inc.	1994-12-07
K935713	WILEY/ESPOSITO DENTAL GUARD	Fvtnks	1994-01-05