The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Dextra Precision Power System.
| Device ID | K853489 |
| 510k Number | K853489 |
| Device Name: | DEXTRA PRECISION POWER SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | CHATTANOOGA GROUP, INC. 101 MEMORIAL DR. Red Bank, TN 37405 |
| Contact | Judy C Londstrom |
| Correspondent | Judy C Londstrom CHATTANOOGA GROUP, INC. 101 MEMORIAL DR. Red Bank, TN 37405 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-20 |
| Decision Date | 1985-09-30 |