Fyodorov Collagen Corneal Shield

FDA 510(k) K862315 · Medical Technology Development Corp.

Substantially Equivalent

510(k) numberK862315

Submission

Device name
Fyodorov Collagen Corneal Shield
Applicant
Medical Technology Development Corp.
Clearwater, FL, US
Received
June 18, 1986
Decision date
January 7, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
MOE – Collagen Corneal Shield
Device class
Class I (low risk)
Regulation
21 CFR 886.4750
Specialty
Ophthalmic

Other 510(k)s with product code MOE

510(k)DeviceApplicantDecision
K944872Bio-Cor Collagen Corneal ShieldMOE · Traditional Bausch & Lomb Healthcare and Optics Worldwide07/26/1995SE
K915861Medilens-Cs Corneal ShieldMOE · Traditional Chiron Ophthalmics03/06/1992SE
K914529Softshield(Tm) 12, 24, 72 Collagen Corneal ShieldsMOE · Traditional Oasis Medical, Inc.11/13/1991SE
K913148Collagen Shield for Acute CareMOE · Traditional Vitaphore Corp.10/15/1991SE
K905825Collagen Shield, Various ModelsMOE · Traditional Chiron Ophthalmics06/10/1991SE
K902558Collagen Shield for Acute CareMOE · Traditional Vitaphore Corp.08/17/1990SE
K901880Medilens(Tm) Corneal ShieldMOE · Traditional Chiron Ophthalmics07/02/1990SE
K896449Im Collagen ShieldMOE · Traditional Intermedical, Inc.05/24/1990SE
K884962Addit. Indications for Bio-Cor Ext Collagen CorneaMOE · Traditional Bausch & Lomb Pharmaceutical, Inc.02/09/1990SE
K885015Coi 72 HR Collagen ShieldMOE · Traditional Chiron Ophthalmics06/23/1989SE

More from Chiron Ophthalmics

510(k)DeviceDecision
K941488Devmed Double-Balloon Urological CatheterEZL · Traditional 11/30/1994SE
K863727Fixation InstrumentsHNR · Traditional 10/31/1986SE
K863725Cataract Diamond KnifeHNN · Traditional 10/31/1986SE
K863726Instrument Sterilization TrayFSM · Traditional 10/14/1986SE

Questions and answers

When was Fyodorov Collagen Corneal Shield cleared by the FDA?

Fyodorov Collagen Corneal Shield (K862315) received a 510(k) decision of Substantially Equivalent on January 7, 1987, 203 days after the submission was received.

What is the product code of K862315?

The FDA product code is MOE – Collagen Corneal Shield, a Class I (low risk) device regulated under 21 CFR 886.4750.