The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Smith Subtalar Peg.
Device ID | K792670 |
510k Number | K792670 |
Device Name: | SMITH SUBTALAR PEG |
Classification | Orthopedic Manual Surgical Instrument |
Applicant | DOW CORNING WRIGHT 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LXH |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-27 |
Decision Date | 1980-02-22 |