The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Buechel-pappas Humeral Head Resurfacing Component.
| Device ID | K992394 |
| 510k Number | K992394 |
| Device Name: | BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079 |
| Contact | John Pappas |
| Correspondent | John Pappas ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-19 |
| Decision Date | 1999-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814193025326 | K992394 | 000 |
| 00814193025319 | K992394 | 000 |
| 00814193025302 | K992394 | 000 |
| 00814193025296 | K992394 | 000 |
| 00814193025289 | K992394 | 000 |