The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Cricothyrotomy Tube.
| Device ID | K983000 |
| 510k Number | K983000 |
| Device Name: | CRICOTHYROTOMY TUBE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | POLAMEDCO, INC. 4054 GLENCOE AVE. Marina Del Rey, CA 90292 -5608 |
| Contact | Jerry W Harrer |
| Correspondent | Jerry W Harrer POLAMEDCO, INC. 4054 GLENCOE AVE. Marina Del Rey, CA 90292 -5608 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-27 |
| Decision Date | 1999-10-27 |
| Summary: | summary |