The following data is part of a premarket notification filed by Rudolph Beaver, Inc. with the FDA for Arthro-trac(tm).
| Device ID | K883361 |
| 510k Number | K883361 |
| Device Name: | ARTHRO-TRAC(TM) |
| Classification | Arthroscope |
| Applicant | RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham, MA 02154 |
| Contact | Robert Zoletti |
| Correspondent | Robert Zoletti RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham, MA 02154 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-09 |
| Decision Date | 1988-10-13 |