The following data is part of a premarket notification filed by Precision Medical Instruments, Inc. with the FDA for Infusion Cannulam.
| Device ID | K852758 |
| 510k Number | K852758 |
| Device Name: | INFUSION CANNULAM |
| Classification | Cannula, Ophthalmic |
| Applicant | PRECISION MEDICAL INSTRUMENTS, INC. 250 BAY VIEW AVE. Belvedere, CA 94720 |
| Contact | Bernard J Dignam |
| Correspondent | Bernard J Dignam PRECISION MEDICAL INSTRUMENTS, INC. 250 BAY VIEW AVE. Belvedere, CA 94720 |
| Product Code | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-28 |
| Decision Date | 1985-08-01 |