The following data is part of a premarket notification filed by Look, Inc. with the FDA for Look Irrigating Cystotomes.
| Device ID | K870439 |
| 510k Number | K870439 |
| Device Name: | LOOK IRRIGATING CYSTOTOMES |
| Classification | Cystotome |
| Applicant | LOOK, INC. 45 CHARLES PARK RD. Boston, MA 02132 |
| Contact | David H Barrett |
| Correspondent | David H Barrett LOOK, INC. 45 CHARLES PARK RD. Boston, MA 02132 |
| Product Code | HNY |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-02-20 |