The following data is part of a premarket notification filed by Anchor Innovation Medical (a.i.m.) with the FDA for A.i.m. Lead Loop Suturing Device (1), A.i.m. Tension Assist/suture Cutter Device, A.i.m. Lead Loop Suturing Device (1) Plus Tension Assist/suture Cutter Device, A.i.m. Lead Loop Suturing Device (2), A.i.m. Lead Loop Suturing Device Plus Tension Assis.
| Device ID | K150924 |
| 510k Number | K150924 |
| Device Name: | A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) Plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device Plus Tension Assis |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | ANCHOR INNOVATION MEDICAL (A.I.M.) 5410 EDSON LANE, SUITE 308 Rockville, MD 20852 |
| Contact | Cary Stalnecker |
| Correspondent | Karen M Becker ANCHOR INNOVATION MEDICAL (A.I.M.) 5410 EDSON LANE, SUITE 308 Rockville, MD 20852 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-06 |
| Decision Date | 2015-07-27 |
| Summary: | summary |