The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Staple Fixation System.
| Device ID | K894929 |
| 510k Number | K894929 |
| Device Name: | STAPLE FIXATION SYSTEM |
| Classification | Staple, Fixation, Bone |
| Applicant | CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
| Contact | Martha Miller |
| Correspondent | Martha Miller CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-02 |
| Decision Date | 1989-08-30 |