The following data is part of a premarket notification filed by Elcare Innovations, Inc. with the FDA for Modification To The Grip.
| Device ID | K010526 |
| 510k Number | K010526 |
| Device Name: | MODIFICATION TO THE GRIP |
| Classification | Aid, Cardiopulmonary Resuscitation |
| Applicant | ELCARE INNOVATIONS, INC. 7101 STEPHENSON-LEVEY RD. Burleson, TX 76028 |
| Contact | Elroy T Cantrell |
| Correspondent | Elroy T Cantrell ELCARE INNOVATIONS, INC. 7101 STEPHENSON-LEVEY RD. Burleson, TX 76028 |
| Product Code | LIX |
| CFR Regulation Number | 870.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-22 |
| Decision Date | 2001-12-13 |