The following data is part of a premarket notification filed by Adroit Medical Systems, Inc. with the FDA for Sterile Soft-temp.
| Device ID | K962983 |
| 510k Number | K962983 |
| Device Name: | STERILE SOFT-TEMP |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | ADROIT MEDICAL SYSTEMS, INC. 1146 CARDING MACHINE RD. Loudon, TN 37774 |
| Contact | Richard L Struder |
| Correspondent | Richard L Struder ADROIT MEDICAL SYSTEMS, INC. 1146 CARDING MACHINE RD. Loudon, TN 37774 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-01 |
| Decision Date | 1997-01-10 |
| Summary: | summary |