The following data is part of a premarket notification filed by Aci Medical, Inc. with the FDA for Micro-tracheostomy Care Kit.
| Device ID | K861645 |
| 510k Number | K861645 |
| Device Name: | MICRO-TRACHEOSTOMY CARE KIT |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | ACI MEDICAL, INC. 8835 MULBERRY DR. P.O. BOX 1134 Sunland, CA 91040 |
| Contact | Edward J Arkans |
| Correspondent | Edward J Arkans ACI MEDICAL, INC. 8835 MULBERRY DR. P.O. BOX 1134 Sunland, CA 91040 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-30 |
| Decision Date | 1986-05-09 |