The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Wright Dow Corning Softgoods W/dow.
Device ID | K792269 |
510k Number | K792269 |
Device Name: | WRIGHT DOW CORNING SOFTGOODS W/DOW |
Classification | Orthosis, Lumbo-sacral |
Applicant | DOW CORNING WRIGHT 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | IPY |
CFR Regulation Number | 890.3490 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-09 |
Decision Date | 1980-02-05 |