The following data is part of a premarket notification filed by Rudolph Beaver, Inc. with the FDA for Mechanical Cystitome.
| Device ID | K862709 |
| 510k Number | K862709 |
| Device Name: | MECHANICAL CYSTITOME |
| Classification | Cystotome |
| Applicant | RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham, MA 02154 |
| Contact | Robert P Zoletti |
| Correspondent | Robert P Zoletti RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham, MA 02154 |
| Product Code | HNY |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-16 |
| Decision Date | 1986-08-01 |