The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Opti-con And E-z Shield Systems.
| Device ID | K964114 |
| 510k Number | K964114 |
| Device Name: | DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS |
| Classification | Mask, Surgical |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1997-05-06 |
| Summary: | summary |