The following data is part of a premarket notification filed by Attachments Intl., Inc. with the FDA for The O-ring System - Ors.
| Device ID | K900099 |
| 510k Number | K900099 |
| Device Name: | THE O-RING SYSTEM - ORS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ATTACHMENTS INTL., INC. 600 S. AMPHLETT BLVD. San Mateo, CA 94402 |
| Contact | Donna Schmidt |
| Correspondent | Donna Schmidt ATTACHMENTS INTL., INC. 600 S. AMPHLETT BLVD. San Mateo, CA 94402 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-08 |
| Decision Date | 1991-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307118718 | K900099 | 000 |
| 10841307118459 | K900099 | 000 |
| 10841307118442 | K900099 | 000 |
| 10841307118435 | K900099 | 000 |
| 10841307118428 | K900099 | 000 |
| 10841307118411 | K900099 | 000 |
| 10841307118404 | K900099 | 000 |
| 10841307118398 | K900099 | 000 |
| 10841307118381 | K900099 | 000 |
| 10841307118374 | K900099 | 000 |
| 10841307118367 | K900099 | 000 |
| 10841307118466 | K900099 | 000 |
| 10841307118473 | K900099 | 000 |
| 10841307118701 | K900099 | 000 |
| 10841307118695 | K900099 | 000 |
| 10841307118688 | K900099 | 000 |
| 10841307118626 | K900099 | 000 |
| 10841307118619 | K900099 | 000 |
| 10841307118602 | K900099 | 000 |
| 10841307118596 | K900099 | 000 |
| 10841307118510 | K900099 | 000 |
| 10841307118503 | K900099 | 000 |
| 10841307118497 | K900099 | 000 |
| 10841307118190 | K900099 | 000 |