The following data is part of a premarket notification filed by Aircast, Inc. with the FDA for Autochill Accessory Kit.
| Device ID | K925677 |
| 510k Number | K925677 |
| Device Name: | AUTOCHILL ACCESSORY KIT |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | AIRCAST, INC. P.O. BOX 709 92 RIVER ROAD Summit, NJ 07902 -0709 |
| Contact | Glenn W Johnson |
| Correspondent | Glenn W Johnson AIRCAST, INC. P.O. BOX 709 92 RIVER ROAD Summit, NJ 07902 -0709 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-16 |
| Decision Date | 1993-04-14 |