The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Smiljanic Bone Repositioning Forceps.
| Device ID | K871535 |
| 510k Number | K871535 |
| Device Name: | SMILJANIC BONE REPOSITIONING FORCEPS |
| Classification | Forceps |
| Applicant | LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor, NJ 07936 |
| Contact | Edward B Schussler |
| Correspondent | Edward B Schussler LINK AMERICA, INC. C/O SURGICAL IMPLANTS, INC. 10 GREAT MEADOW LANE East Hanavor, NJ 07936 |
| Product Code | HTD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-20 |
| Decision Date | 1987-05-14 |