The following data is part of a premarket notification filed by Advanced Biosearch Assn. with the FDA for Manual Surgical Instruments & Access.champy Bone P.
| Device ID | K855031 |
| 510k Number | K855031 |
| Device Name: | MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P |
| Classification | Screw, Fixation, Bone |
| Applicant | ADVANCED BIOSEARCH ASSN. 1700 ROCKVILLE PIKE SUITE 320 Rockville, MD 20852 |
| Contact | Joel S Faden |
| Correspondent | Joel S Faden ADVANCED BIOSEARCH ASSN. 1700 ROCKVILLE PIKE SUITE 320 Rockville, MD 20852 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-16 |
| Decision Date | 1986-01-21 |