The following data is part of a premarket notification filed by Intl. Health Technology, Inc. with the FDA for Scalp Hydrobath/treatment Delivery System.
| Device ID | K883187 |
| 510k Number | K883187 |
| Device Name: | SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM |
| Classification | Bath, Hydro-massage |
| Applicant | INTL. HEALTH TECHNOLOGY, INC. 2119 24TH AVE. N. Nashville, TN 37208 |
| Contact | Myles Izikoff |
| Correspondent | Myles Izikoff INTL. HEALTH TECHNOLOGY, INC. 2119 24TH AVE. N. Nashville, TN 37208 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-28 |
| Decision Date | 1988-10-27 |