The following data is part of a premarket notification filed by Allegheny Plastics, Inc. with the FDA for Rule, Pupillary.
| Device ID | K873440 |
| 510k Number | K873440 |
| Device Name: | RULE, PUPILLARY |
| Classification | Distometer |
| Applicant | ALLEGHENY PLASTICS, INC. THORN RUN RD. & RT 51 Coraopolis, PA 15108 |
| Contact | Douglas F Turner |
| Correspondent | Douglas F Turner ALLEGHENY PLASTICS, INC. THORN RUN RD. & RT 51 Coraopolis, PA 15108 |
| Product Code | HMM |
| CFR Regulation Number | 886.1190 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-27 |
| Decision Date | 1987-09-21 |