The following data is part of a premarket notification filed by Sutter Corp. with the FDA for Sutter Model 6000 Hand Cpm Device.
| Device ID | K945221 |
| 510k Number | K945221 |
| Device Name: | SUTTER MODEL 6000 HAND CPM DEVICE |
| Classification | Exerciser, Powered |
| Applicant | SUTTER CORP. 9465 FARNHAM ST. San Diego, CA 92123 |
| Contact | Louise M Focht |
| Correspondent | Louise M Focht SUTTER CORP. 9465 FARNHAM ST. San Diego, CA 92123 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-26 |
| Decision Date | 1995-02-27 |