Eptfe Sheet Covering for Ocular Implant
FDA 510(k) K934834 · Oculo Plastik, Inc.
510(k) numberK934834
Submission
- Device name
- Eptfe Sheet Covering for Ocular Implant
- Applicant
- Oculo Plastik, Inc.
Montreal, Quebec Canada, CA - Received
- October 8, 1993
- Decision date
- May 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HPZ – Implant, Eye Sphere
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3320
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code HPZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212741 | EzyporHPZ · Traditional | Fci (France Chirurgie Instrumentation) Sas | 06/24/2022SE |
| K123764 | Durette Ocular ImplantHPZ · Traditional | Oculo-Plastik, Inc. | 01/31/2013SE |
| K110554 | Bioceramic Orbital Implant, OrbtexHPZ · Traditional | Ceramisys, Ltd. | 11/02/2011SE |
| K112176 | Silicone SpheresHPZ · Special | Oculo Plastik, Inc. | 09/15/2011SE |
| K083342 | Orbital Reconstructive Implant IIHPZ · Traditional | Evera Medical, Inc. | 03/12/2009SE |
| K082850 | Eye SpheresHPZ · Traditional | Product and Educational Services, LLC | 02/27/2009SE |
| K073293 | Durette ImplantHPZ · Traditional | Oculo Plastik, Inc. | 03/19/2008SE |
| K071335 | Medpor Attractor ImplantHPZ · Traditional | Porex Surgical, Inc. | 08/08/2007SE |
| K070130 | Orbital Reconstructive ImplantHPZ · Traditional | Becker & Associates Consulting, Inc. | 04/19/2007SE |
| K053298 | Alphasphere Orbital ImplantHPZ · Traditional | Hydron Pty Limited | 05/09/2006SE |
More from Hydron Pty Limited
| 510(k) | Device | Decision |
|---|---|---|
| K123764 | Durette Ocular ImplantHPZ · Traditional | 01/31/2013SE |
| K112176 | Silicone SpheresHPZ · Special | 09/15/2011SE |
| K073293 | Durette ImplantHPZ · Traditional | 03/19/2008SE |
| K040689 | Eye Sphere ImplantsHPZ · Traditional | 06/10/2004SE |
| K915630 | OphtimplantHPZ · Traditional | 03/02/1992SE |
| K901002 | O'Donnell, Socket Reconstruction ProsthesesHQX · Traditional | 05/22/1990SE |
| K900929 | Putterman-Scott, Socket Reconstruction BilateralHQX · Traditional | 05/18/1990SE |
| K900930 | Spivey-Allen Orbital Floor ImplantHQX · Traditional | 05/15/1990SE |
| K900928 | Cox Malar Eminence ImplantsHQX · Traditional | 05/15/1990SE |
| K900927 | Codere-Durette Orbital Floor ImplantHQX · Traditional | 05/15/1990SE |
Questions and answers
When was Eptfe Sheet Covering for Ocular Implant cleared by the FDA?
Eptfe Sheet Covering for Ocular Implant (K934834) received a 510(k) decision of Substantially Equivalent on May 5, 1994, 209 days after the submission was received.
What is the product code of K934834?
The FDA product code is HPZ – Implant, Eye Sphere, a Class II (moderate risk) device regulated under 21 CFR 886.3320.