The following data is part of a premarket notification filed by "o" Co., Inc. with the FDA for Immediate Stabilizing Device (isd).
| Device ID | K011524 |
| 510k Number | K011524 |
| Device Name: | IMMEDIATE STABILIZING DEVICE (ISD) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | "O" CO., INC. 600 PAISANO, N.E., SUITE A Albuquerque, NM 87123 |
| Contact | David D Dalise |
| Correspondent | David D Dalise "O" CO., INC. 600 PAISANO, N.E., SUITE A Albuquerque, NM 87123 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-17 |
| Decision Date | 2002-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D785SDI2212OB0 | K011524 | 000 |
| D785SDI2516OB0 | K011524 | 000 |
| D785SDI2516CB0 | K011524 | 000 |
| D785SDI2514OB0 | K011524 | 000 |
| D785SDI2514CB0 | K011524 | 000 |
| D785SDI2512OB0 | K011524 | 000 |
| D785SDI2512CB0 | K011524 | 000 |
| D785SDI2510OB0 | K011524 | 000 |
| D785SDI2510CB0 | K011524 | 000 |
| D785SDI2216CB0 | K011524 | 000 |
| D785SDI2214CB0 | K011524 | 000 |
| D785SDI2212CB0 | K011524 | 000 |
| D785SDI2225CBTI0 | K011524 | 000 |
| D785SDI2908CB0 | K011524 | 000 |
| D785SDI2908OB0 | K011524 | 000 |
| D785SDI2210OB0 | K011524 | 000 |
| D785SDI2216OB0 | K011524 | 000 |
| D785SDI2214OB0 | K011524 | 000 |
| D785SDI2210CB0 | K011524 | 000 |
| D785SDI2916OB0 | K011524 | 000 |
| D785SDI2916CB0 | K011524 | 000 |
| D785SDI2914OB0 | K011524 | 000 |
| D785SDI2914CB0 | K011524 | 000 |
| D785SDI2912OB0 | K011524 | 000 |
| D785SDI2912CB0 | K011524 | 000 |
| D785SDI2910OB0 | K011524 | 000 |
| D785SDI2910CB0 | K011524 | 000 |
| D785293325CBTI0 | K011524 | 000 |