The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Sureloc Circuit Connector.
| Device ID | K954383 |
| 510k Number | K954383 |
| Device Name: | SURELOC CIRCUIT CONNECTOR |
| Classification | Connector, Airway (extension) |
| Applicant | POLAMEDCO, INC. 4054 GLENCOE AVE. Marina Del Rey, CA 90292 -5608 |
| Contact | Corey Selman |
| Correspondent | Corey Selman POLAMEDCO, INC. 4054 GLENCOE AVE. Marina Del Rey, CA 90292 -5608 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-19 |
| Decision Date | 1995-12-22 |