The following data is part of a premarket notification filed by Hinson And Hale Medical Technologies, Inc with the FDA for Next Generation Infused (r) Or Towel (hemed), Next Generation Infused (r) Or Towel (with Binding) Model Huckcr17x27mh, H.
| Device ID | K094016 |
| 510k Number | K094016 |
| Device Name: | NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H |
| Classification | Drape, Surgical |
| Applicant | HINSON AND HALE MEDICAL TECHNOLOGIES, INC 7809 ADELAIDE DRIVE Austin, TX 78739 |
| Contact | Jeffrey O Stull |
| Correspondent | Jeffrey O Stull HINSON AND HALE MEDICAL TECHNOLOGIES, INC 7809 ADELAIDE DRIVE Austin, TX 78739 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-29 |
| Decision Date | 2010-11-19 |