The following data is part of a premarket notification filed by Research Development Corp. with the FDA for Hsc Unit Rod.
Device ID | K871870 |
510k Number | K871870 |
Device Name: | HSC UNIT ROD |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | RESEARCH DEVELOPMENT CORP. 88 ELM ST. TORONTO Canada, CA M5g 1x8 |
Contact | Barbara Lavers |
Correspondent | Barbara Lavers RESEARCH DEVELOPMENT CORP. 88 ELM ST. TORONTO Canada, CA M5g 1x8 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-13 |
Decision Date | 1987-07-21 |