The following data is part of a premarket notification filed by Paladin Medical, Inc. with the FDA for Endo-bend(tm) Shaver.
| Device ID | K950054 |
| 510k Number | K950054 |
| Device Name: | ENDO-BEND(TM) SHAVER |
| Classification | Arthroscope |
| Applicant | PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater, MN 55082 -0560 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-06 |
| Decision Date | 1995-06-29 |