Collagen Shield, Various Models
FDA 510(k) K905825 · Chiron Ophthalmics
510(k) numberK905825
Submission
- Device name
- Collagen Shield, Various Models
- Applicant
- Chiron Ophthalmics
Irvine, CA, US - Received
- December 31, 1990
- Decision date
- June 10, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K944872 | Bio-Cor Collagen Corneal ShieldMOE · Traditional | Bausch & Lomb Healthcare and Optics Worldwide | 07/26/1995SE |
| K915861 | Medilens-Cs Corneal ShieldMOE · Traditional | Chiron Ophthalmics | 03/06/1992SE |
| K914529 | Softshield(Tm) 12, 24, 72 Collagen Corneal ShieldsMOE · Traditional | Oasis Medical, Inc. | 11/13/1991SE |
| K913148 | Collagen Shield for Acute CareMOE · Traditional | Vitaphore Corp. | 10/15/1991SE |
| K902558 | Collagen Shield for Acute CareMOE · Traditional | Vitaphore Corp. | 08/17/1990SE |
| K901880 | Medilens(Tm) Corneal ShieldMOE · Traditional | Chiron Ophthalmics | 07/02/1990SE |
| K896449 | Im Collagen ShieldMOE · Traditional | Intermedical, Inc. | 05/24/1990SE |
| K884962 | Addit. Indications for Bio-Cor Ext Collagen CorneaMOE · Traditional | Bausch & Lomb Pharmaceutical, Inc. | 02/09/1990SE |
| K885015 | Coi 72 HR Collagen ShieldMOE · Traditional | Chiron Ophthalmics | 06/23/1989SE |
| K884961 | Addit. Indications for Bio-Cor II Collagen CornealMOE · Traditional | Bausch & Lomb Pharmaceutical, Inc. | 02/13/1989SE |
More from Bausch & Lomb Pharmaceutical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915861 | Medilens-Cs Corneal ShieldMOE · Traditional | 03/06/1992SE |
| K914311 | Chiroflex II Lens Microsert(Tm)HQL · Traditional | 01/27/1992SE |
| K903575 | Chiroflex ForcepsKYB · Traditional | 12/21/1990SE |
| K903574 | Chiroflex Lens MicrosertKYB · Traditional | 09/17/1990SE |
| K901880 | Medilens(Tm) Corneal ShieldMOE · Traditional | 07/02/1990SE |
| K894162 | OptisolLYX · Traditional | 01/12/1990SE |
| K885015 | Coi 72 HR Collagen ShieldMOE · Traditional | 06/23/1989SE |
| K885016 | Coi 24 HR Collagen ShieldMOE · Traditional | 02/01/1989SE |
| K882762 | Collagen ShieldMOE · Traditional | 09/12/1988SE |
Questions and answers
When was Collagen Shield, Various Models cleared by the FDA?
Collagen Shield, Various Models (K905825) received a 510(k) decision of Substantially Equivalent on June 10, 1991, 161 days after the submission was received.
What is the product code of K905825?
The FDA product code is MOE – Collagen Corneal Shield, a Class I (low risk) device regulated under 21 CFR 886.4750.