The following data is part of a premarket notification filed by Hinson And Hale Medical Technologies, Inc with the FDA for Hinson & Hale Medical Technologies Infused (r) Polyester Wrappers.
| Device ID | K102783 |
| 510k Number | K102783 |
| Device Name: | HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS |
| Classification | Wrap, Sterilization |
| 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 | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-27 |
| Decision Date | 2010-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810019800665 | K102783 | 000 |
| 00810019800658 | K102783 | 000 |
| 00810019800641 | K102783 | 000 |
| 00810019800634 | K102783 | 000 |