The following data is part of a premarket notification filed by Smith And Nephew Donjoy, Inc. with the FDA for Model 1100 Cold Therapy Device.
| Device ID | K955057 |
| 510k Number | K955057 |
| Device Name: | MODEL 1100 COLD THERAPY DEVICE |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Contact | Dan W Miller |
| Correspondent | Dan W Miller SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-06 |
| Decision Date | 1996-03-08 |
| Summary: | summary |