The following data is part of a premarket notification filed by Rudolph Beaver, Inc. with the FDA for Beaver R-k Knife.
| Device ID | K852828 |
| 510k Number | K852828 |
| Device Name: | BEAVER R-K KNIFE |
| Classification | Knife, Ophthalmic |
| Applicant | RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham, MA 02154 |
| Contact | Ed Lee |
| Correspondent | Ed Lee RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham, MA 02154 |
| Product Code | HNN |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-02 |
| Decision Date | 1985-11-04 |