The following data is part of a premarket notification filed by Allo Pro Corp. with the FDA for Gsb Elbow.
| Device ID | K901581 |
| 510k Number | K901581 |
| Device Name: | GSB ELBOW |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
| Contact | K Pierpoint |
| Correspondent | K Pierpoint ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-04 |
| Decision Date | 1990-10-22 |