The following data is part of a premarket notification filed by Avitar, Inc. with the FDA for Hydrasorb(tm).
| Device ID | K897102 |
| 510k Number | K897102 |
| Device Name: | HYDRASORB(TM) |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | AVITAR, INC. 250 TURNPIKE ST. Canton, MA 02021 |
| Contact | Paul H Patrone |
| Correspondent | Paul H Patrone AVITAR, INC. 250 TURNPIKE ST. Canton, MA 02021 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-21 |
| Decision Date | 1990-04-23 |