The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Pelvic Radius Plate.
Device ID | K936233 |
510k Number | K936233 |
Device Name: | PELVIC RADIUS PLATE |
Classification | Plate, Fixation, Bone |
Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
Contact | Thomas L Craig |
Correspondent | Thomas L Craig SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-29 |
Decision Date | 1994-08-01 |