The following data is part of a premarket notification filed by Orthofab, Inc. with the FDA for Apollo Sterile Blades.
| Device ID | K852661 |
| 510k Number | K852661 |
| Device Name: | APOLLO STERILE BLADES |
| Classification | Blade, Scalpel |
| Applicant | ORTHOFAB, INC. 7464 IRVIN AVE. SOUTH Cottage Grove, MN 55016 |
| Contact | H Barrows |
| Correspondent | H Barrows ORTHOFAB, INC. 7464 IRVIN AVE. SOUTH Cottage Grove, MN 55016 |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-24 |
| Decision Date | 1985-07-11 |