The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Incare Hot/ice Lite Machine.
| Device ID | K962537 |
| 510k Number | K962537 |
| Device Name: | INCARE HOT/ICE LITE MACHINE |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Contact | Joseph S Tokarz |
| Correspondent | Joseph S Tokarz HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-28 |
| Decision Date | 1996-11-27 |
| Summary: | summary |