The following data is part of a premarket notification filed by Burke Neutech, Inc. with the FDA for Sports Contrast Therapy System St 7000.
| Device ID | K955326 |
| 510k Number | K955326 |
| Device Name: | SPORTS CONTRAST THERAPY SYSTEM ST 7000 |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | BURKE NEUTECH, INC. 1765 COMMERCE AVE. NORTH St. Petersburg, FL 33716 |
| Contact | Robert E Burke |
| Correspondent | Robert E Burke BURKE NEUTECH, INC. 1765 COMMERCE AVE. NORTH St. Petersburg, FL 33716 |
| 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 | 1995-11-20 |
| Decision Date | 1996-04-10 |