The following data is part of a premarket notification filed by Sutter Corp. with the FDA for Sutter Proximal Interphalangeal Joint.
| Device ID | K931588 |
| 510k Number | K931588 |
| Device Name: | SUTTER PROXIMAL INTERPHALANGEAL JOINT |
| Classification | Prosthesis, Finger, Constrained, Polymer |
| Applicant | SUTTER CORP. 9425 CHESAPEAKE DR. San Diego, CA 92123 |
| Contact | Louise M Focht |
| Correspondent | Louise M Focht SUTTER CORP. 9425 CHESAPEAKE DR. San Diego, CA 92123 |
| Product Code | KYJ |
| CFR Regulation Number | 888.3230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-31 |
| Decision Date | 1994-03-10 |