The following data is part of a premarket notification filed by Noetix, Inc. with the FDA for Capsulectomer Cystotome.
| Device ID | K871365 |
| 510k Number | K871365 |
| Device Name: | CAPSULECTOMER CYSTOTOME |
| Classification | Cystotome |
| Applicant | NOETIX, INC. 5670 N. MERIDIAN Indianapolis, IN 46208 |
| Contact | Joseph L Mark |
| Correspondent | Joseph L Mark NOETIX, INC. 5670 N. MERIDIAN Indianapolis, IN 46208 |
| Product Code | HNY |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-07 |
| Decision Date | 1987-04-16 |