The following data is part of a premarket notification filed by Sutter Biomedical, Inc. with the FDA for Sutter Lesser Metatarsal Cap.
| Device ID | K861983 |
| 510k Number | K861983 |
| Device Name: | SUTTER LESSER METATARSAL CAP |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| Applicant | SUTTER BIOMEDICAL, INC. 3940 RUFFIN RD. San Diego, CA 92123 |
| Contact | Mizoguchi, Phd |
| Correspondent | Mizoguchi, Phd SUTTER BIOMEDICAL, INC. 3940 RUFFIN RD. San Diego, CA 92123 |
| Product Code | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-22 |
| Decision Date | 1986-09-08 |